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    • Imfinzi (Durvalumab)

    Check Drug InteractionsCheck known drug interactions.
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    Dosage & administration

    Neoadjuvant
    : IMFINZI 1,500 mg in combination with chemotherapy every 3 weeks for up to 4 cycles prior to surgery.

    Adjuvant
    : IMFINZI 1,500 mg as a single agent every 4 weeks for up to 12 cycles after surgery. (
    2.2 Recommended Dosage

    The recommended dosages for IMFINZI as a single agent and IMFINZI in combination with other therapeutic agents are presented in Table 1. The recommended dosage schedule and regimens for IMFINZI for the treatment of metastatic NSCLC are provided in Tables 2 and 3

    [see Indications and Usage (1.1)].

    Administer IMFINZI as a 60 minute intravenous infusion after dilution

    [ see Dosage and Administration (2.3)].

    Table 1. Recommended Dosages of IMFINZI
    Indication
    Recommended IMFINZI Dosage
    Duration of Therapy
    Neoadjuvant and Adjuvant Treatment of Resectable NSCLC
    Patients with a body weight of ≥ 30 kg:


    Neoadjuvant: IMFINZI 1,500 mg in combination with chemotherapy
    Administer IMFINZI prior to chemotherapy on the same day. Refer to the Prescribing Information for the agent administered in combination with IMFINZI for recommended dosage information, as appropriate.
    every 3 weeks for up to 4 cycles prior to surgery


    Adjuvant: IMFINZI 1,500 mg as a single agent every 4 weeks for up to 12 cycles after surgery.


    Patients with a body weight of < 30 kg:

    Neoadjuvant: IMFINZI 20 mg/kg every 3 weeks in combination with chemotherapy
    for up to 4 cycles prior to surgery.

    Adjuvant: IMFINZI 20 mg/kg every 4 weeks for up to 12 cycles as a single agent after surgery.
    Until disease progression that precludes definitive surgery, recurrence, unacceptable toxicity, or a maximum of 12 cycles after surgery
    Unresectable Stage III NSCLCFollowing concurrent platinum-based chemotherapy and radiation therapy:

    Patients with a body weight of ≥ 30 kg:

    10 mg/kg every 2 weeks

    or

    1,500 mg every 4 weeks

    Patients with a body weight of < 30 kg:

    10 mg/kg every 2 weeks    		Until disease progression, unacceptable toxicity, or a maximum of 12 months
    Limited Stage SCLCFollowing concurrent platinum-based chemotherapy and radiation therapy:

    Patients with a body weight of ≥ 30 kg:

    1,500 mg every 4 weeks


    Patients with a body weight of < 30 kg:

    20 mg/kg every 4 weeks
    		Until disease progression, unacceptable toxicity, or a maximum of 24 months
    Extensive Stage SCLCPatients with a body weight of ≥ 30 kg:

    1,500 mg in combination with chemotherapy
    every 3 weeks (21 days) for 4 cycles, followed by 1,500 mg every 4 weeks as a single agent

    Patients with a body weight of < 30 kg:

    20 mg/kg in combination with chemotherapy
    every 3 weeks (21 days) for 4 cycles, followed by 10 mg/kg every 2 weeks as a single agent    		Until disease progression or until unacceptable toxicity
    BTCPatients with a body weight of ≥ 30 kg:

    1,500 mg in combination with chemotherapy
    every 3 weeks (21 days) up to 8 cycles followed by 1,500 mg every 4 weeks as a single agent

    Patients with a body weight of < 30 kg:

    20 mg/kg in combination with chemotherapy
    every 3 weeks (21 days) up to 8 cycles, followed by 20 mg/kg every 4 weeks as a single agent    		Until disease progression or until unacceptable toxicity
    uHCCPatients with a body weight of ≥ 30 kg:

    IMFINZI 1,500 mg following a single dose of tremelimumab-actlAdminister tremelimumab-actl prior to IMFINZI on the same day. When tremelimumab-actl is administered in combination with IMFINZI, refer to the Prescribing Information for tremelimumab-actl dosing information.300 mg at Day 1 of Cycle 1;

    Continue IMFINZI 1,500 mg as a single agent every 4 weeks

    Patients with a body weight of < 30 kg:

    IMFINZI 20 mg/kg following a single dose of tremelimumab-actl
    4 mg/kg at Day 1 of Cycle 1;

    Continue IMFINZI 20 mg/kg as a single agent every 4 weeks    		After Cycle 1 of combination therapy, administer IMFINZI as a single agent every 4 weeks until disease progression or unacceptable toxicity
    dMMR endometrial cancer
    Patients with a body weight of ≥ 30 kg:


    IMFINZI 1,120 mg in combination with carboplatin and paclitaxel
    every 3 weeks (21 days) for 6 cycles, followed by IMFINZI 1,500 mg every 4 weeks as a single agent


    Patients with a body weight of < 30 kg:


    IMFINZI 15 mg/kg in combination with carboplatin and paclitaxel
    every 3 weeks (21 days) for 6 cycles, followed by IMFINZI 20 mg/kg every 4 weeks as a single agent
    Until disease progression or unacceptable toxicity
    Neoadjuvant and Adjuvant Treatment of MIBC
    Patients with a body weight of ≥30 kg:


    Neoadjuvant: 1,500 mg in combination with gemcitabine and cisplatin
    every 3 weeks for 4 cycles prior to surgery


    Adjuvant: IMFINZI 1,500 mg as a single agent every 4 weeks for up to 8 cycles after surgery


    Patients with a body weight of < 30 kg:


    Neoadjuvant: 20 mg/kg in combination with gemcitabine and cisplatin
    every 3 weeks for 4 cycles prior to surgery


    Adjuvant: IMFINZI 20 mg/kg as a single agent every 4 weeks for up to 8 cycles after surgery
    Until disease progression that precludes definitive surgery, recurrence, or unacceptable toxicity or a maximum of 8 cycles after surgery
    Neoadjuvant and Adjuvant


    Treatment of Resectable


    GC/GEJC
    Patients with a body weight of ≥ 30


    kg:


    Neoadjuvant: IMFINZI 1,500 mg every 4 weeks with FLOT
    FLOT chemotherapy is administered on days 1 and 15 of each 4 week cycle
    [See Clinical Studies ]
    .
    for up to 2 cycles prior to surgery


    Adjuvant: IMFINZI 1,500 mg every 4 weeks with FLOT
    for up to 2 cycles, followed by IMFINZI 1,500 mg as a single agent every 4 weeks for up to 10 cycles


    Patients with a body weight of < 30 kg:


    Neoadjuvant: IMFINZI 20 mg/kg every 4 weeks with FLOT*± for up to 2 cycles prior to surgery


    Adjuvant: IMFINZI 20 mg/kg every 4 weeks with FLOT
    for up to 2 cycles, followed by IMFINZI 20 mg/kg as a single agent every 4 weeks for up to 10 cycles
    Neoadjuvant: Until disease progression that precludes definitive surgery or unacceptable toxicity

    IMFINZI in Combination with Tremelimumab-actl and Platinum-Based Chemotherapy

    The recommended dosage schedule and regimens for IMFINZI for the treatment of metastatic NSCLC are provided in Tables 2 and 3.

    Weigh patients prior to each infusion.

    Calculate the appropriate dose using Table 3 below based on the patient’s weight and tumor histology.

    Table 2. Recommended Dosage Schedule for Metastatic NSCLC
    Week
    continue IMFINZI until disease progression or intolerable toxicity.note the dosing interval change from every 3 weeks to every 4 weeks starting at cycle 5.
    0123456789101112131415161718192021222324
    Cycle:
    		12345678

    IMFINZI

    intravenous infusion over 60 minutes
    [see
    Dosage and Administration (2.4)
    ]
    .

    X

    X

    X

    X

    X

    X

    X

    X

    Tremelimumab-actl

    if patients receive fewer than 4 cycles of platinum-based chemotherapy, the remaining cycles of tremelimumab-actl (up to a total of 5) should be given after the platinum-based chemotherapy phase, in combination with IMFINZI, every 4 weeks.

    X

    X

    X

    X

    X

    Chemotherapy

    X

    X

    X

    X

    Xoptional pemetrexed therapy from week 12 until disease progression or intolerable toxicity for patients with non-squamous disease who received treatment with pemetrexed and carboplatin/cisplatin.

    X

    X

    X


    OR




    OR



    Table 3. Recommended Regimen and Dosage for Metastatic NSCLC
    Tumor Histology
    Patient Weight
    IMFINZI Dosage
    Tremelimumab-actl DosageRefer to the Prescribing Information for dosing information.
    Platinum-based Chemotherapy Regimen

    Non-Squamous

    ≥ 30 kg

    1,500 mg

    75 mg


    ••

    < 30 kg

    20 mg/kg

    1 mg/kg

    Squamous

    ≥ 30 kg

    1,500 mg

    75 mg


    ••

    < 30 kg

    20 mg/kg

    1 mg/kg

    carboplatin & nab-paclitaxelcarboplatin or cisplatin & pemetrexedcarboplatin & nab-paclitaxelcarboplatin or cisplatin & gemcitabine
    )


    Neoadjuvant
    : IMFINZI 20 mg/kg every 3 weeks in combination with chemotherapy for up to 4 cycles prior to surgery.

    Adjuvant
    : 20 mg/kg every 4 weeks as a single agent for up to 12 cycles after surgery. (
    2.2 Recommended Dosage

    The recommended dosages for IMFINZI as a single agent and IMFINZI in combination with other therapeutic agents are presented in Table 1. The recommended dosage schedule and regimens for IMFINZI for the treatment of metastatic NSCLC are provided in Tables 2 and 3

    [see Indications and Usage (1.1)].

    Administer IMFINZI as a 60 minute intravenous infusion after dilution

    [ see Dosage and Administration (2.3)].

    Table 1. Recommended Dosages of IMFINZI
    Indication
    Recommended IMFINZI Dosage
    Duration of Therapy
    Neoadjuvant and Adjuvant Treatment of Resectable NSCLC
    Patients with a body weight of ≥ 30 kg:


    Neoadjuvant: IMFINZI 1,500 mg in combination with chemotherapy
    Administer IMFINZI prior to chemotherapy on the same day. Refer to the Prescribing Information for the agent administered in combination with IMFINZI for recommended dosage information, as appropriate.
    every 3 weeks for up to 4 cycles prior to surgery


    Adjuvant: IMFINZI 1,500 mg as a single agent every 4 weeks for up to 12 cycles after surgery.


    Patients with a body weight of < 30 kg:

    Neoadjuvant: IMFINZI 20 mg/kg every 3 weeks in combination with chemotherapy
    for up to 4 cycles prior to surgery.

    Adjuvant: IMFINZI 20 mg/kg every 4 weeks for up to 12 cycles as a single agent after surgery.
    Until disease progression that precludes definitive surgery, recurrence, unacceptable toxicity, or a maximum of 12 cycles after surgery
    Unresectable Stage III NSCLCFollowing concurrent platinum-based chemotherapy and radiation therapy:

    Patients with a body weight of ≥ 30 kg:

    10 mg/kg every 2 weeks

    or

    1,500 mg every 4 weeks

    Patients with a body weight of < 30 kg:

    10 mg/kg every 2 weeks    		Until disease progression, unacceptable toxicity, or a maximum of 12 months
    Limited Stage SCLCFollowing concurrent platinum-based chemotherapy and radiation therapy:

    Patients with a body weight of ≥ 30 kg:

    1,500 mg every 4 weeks


    Patients with a body weight of < 30 kg:

    20 mg/kg every 4 weeks
    		Until disease progression, unacceptable toxicity, or a maximum of 24 months
    Extensive Stage SCLCPatients with a body weight of ≥ 30 kg:

    1,500 mg in combination with chemotherapy
    every 3 weeks (21 days) for 4 cycles, followed by 1,500 mg every 4 weeks as a single agent

    Patients with a body weight of < 30 kg:

    20 mg/kg in combination with chemotherapy
    every 3 weeks (21 days) for 4 cycles, followed by 10 mg/kg every 2 weeks as a single agent    		Until disease progression or until unacceptable toxicity
    BTCPatients with a body weight of ≥ 30 kg:

    1,500 mg in combination with chemotherapy
    every 3 weeks (21 days) up to 8 cycles followed by 1,500 mg every 4 weeks as a single agent

    Patients with a body weight of < 30 kg:

    20 mg/kg in combination with chemotherapy
    every 3 weeks (21 days) up to 8 cycles, followed by 20 mg/kg every 4 weeks as a single agent    		Until disease progression or until unacceptable toxicity
    uHCCPatients with a body weight of ≥ 30 kg:

    IMFINZI 1,500 mg following a single dose of tremelimumab-actlAdminister tremelimumab-actl prior to IMFINZI on the same day. When tremelimumab-actl is administered in combination with IMFINZI, refer to the Prescribing Information for tremelimumab-actl dosing information.300 mg at Day 1 of Cycle 1;

    Continue IMFINZI 1,500 mg as a single agent every 4 weeks

    Patients with a body weight of < 30 kg:

    IMFINZI 20 mg/kg following a single dose of tremelimumab-actl
    4 mg/kg at Day 1 of Cycle 1;

    Continue IMFINZI 20 mg/kg as a single agent every 4 weeks    		After Cycle 1 of combination therapy, administer IMFINZI as a single agent every 4 weeks until disease progression or unacceptable toxicity
    dMMR endometrial cancer
    Patients with a body weight of ≥ 30 kg:


    IMFINZI 1,120 mg in combination with carboplatin and paclitaxel
    every 3 weeks (21 days) for 6 cycles, followed by IMFINZI 1,500 mg every 4 weeks as a single agent


    Patients with a body weight of < 30 kg:


    IMFINZI 15 mg/kg in combination with carboplatin and paclitaxel
    every 3 weeks (21 days) for 6 cycles, followed by IMFINZI 20 mg/kg every 4 weeks as a single agent
    Until disease progression or unacceptable toxicity
    Neoadjuvant and Adjuvant Treatment of MIBC
    Patients with a body weight of ≥30 kg:


    Neoadjuvant: 1,500 mg in combination with gemcitabine and cisplatin
    every 3 weeks for 4 cycles prior to surgery


    Adjuvant: IMFINZI 1,500 mg as a single agent every 4 weeks for up to 8 cycles after surgery


    Patients with a body weight of < 30 kg:


    Neoadjuvant: 20 mg/kg in combination with gemcitabine and cisplatin
    every 3 weeks for 4 cycles prior to surgery


    Adjuvant: IMFINZI 20 mg/kg as a single agent every 4 weeks for up to 8 cycles after surgery
    Until disease progression that precludes definitive surgery, recurrence, or unacceptable toxicity or a maximum of 8 cycles after surgery
    Neoadjuvant and Adjuvant


    Treatment of Resectable


    GC/GEJC
    Patients with a body weight of ≥ 30


    kg:


    Neoadjuvant: IMFINZI 1,500 mg every 4 weeks with FLOT
    FLOT chemotherapy is administered on days 1 and 15 of each 4 week cycle
    [See Clinical Studies ]
    .
    for up to 2 cycles prior to surgery


    Adjuvant: IMFINZI 1,500 mg every 4 weeks with FLOT
    for up to 2 cycles, followed by IMFINZI 1,500 mg as a single agent every 4 weeks for up to 10 cycles


    Patients with a body weight of < 30 kg:


    Neoadjuvant: IMFINZI 20 mg/kg every 4 weeks with FLOT*± for up to 2 cycles prior to surgery


    Adjuvant: IMFINZI 20 mg/kg every 4 weeks with FLOT
    for up to 2 cycles, followed by IMFINZI 20 mg/kg as a single agent every 4 weeks for up to 10 cycles
    Neoadjuvant: Until disease progression that precludes definitive surgery or unacceptable toxicity

    IMFINZI in Combination with Tremelimumab-actl and Platinum-Based Chemotherapy

    The recommended dosage schedule and regimens for IMFINZI for the treatment of metastatic NSCLC are provided in Tables 2 and 3.

    Weigh patients prior to each infusion.

    Calculate the appropriate dose using Table 3 below based on the patient’s weight and tumor histology.

    Table 2. Recommended Dosage Schedule for Metastatic NSCLC
    Week
    continue IMFINZI until disease progression or intolerable toxicity.note the dosing interval change from every 3 weeks to every 4 weeks starting at cycle 5.
    0123456789101112131415161718192021222324
    Cycle:
    		12345678

    IMFINZI

    intravenous infusion over 60 minutes
    [see
    Dosage and Administration (2.4)
    ]
    .

    X

    X

    X

    X

    X

    X

    X

    X

    Tremelimumab-actl

    if patients receive fewer than 4 cycles of platinum-based chemotherapy, the remaining cycles of tremelimumab-actl (up to a total of 5) should be given after the platinum-based chemotherapy phase, in combination with IMFINZI, every 4 weeks.

    X

    X

    X

    X

    X

    Chemotherapy

    X

    X

    X

    X

    Xoptional pemetrexed therapy from week 12 until disease progression or intolerable toxicity for patients with non-squamous disease who received treatment with pemetrexed and carboplatin/cisplatin.

    X

    X

    X


    OR




    OR



    Table 3. Recommended Regimen and Dosage for Metastatic NSCLC
    Tumor Histology
    Patient Weight
    IMFINZI Dosage
    Tremelimumab-actl DosageRefer to the Prescribing Information for dosing information.
    Platinum-based Chemotherapy Regimen

    Non-Squamous

    ≥ 30 kg

    1,500 mg

    75 mg


    ••

    < 30 kg

    20 mg/kg

    1 mg/kg

    Squamous

    ≥ 30 kg

    1,500 mg

    75 mg


    ••

    < 30 kg

    20 mg/kg

    1 mg/kg

    carboplatin & nab-paclitaxelcarboplatin or cisplatin & pemetrexedcarboplatin & nab-paclitaxelcarboplatin or cisplatin & gemcitabine
    )


    Neoadjuvant:
    IMFINZI 1,500 mg in combination with gemcitabine and cisplatin every 3 weeks for 4 cycles prior to surgery.

    Adjuvant:
    IMFINZI 1,500 mg every 4 weeks as a single agent for up to 8 cycles after surgery. (
    2.2 Recommended Dosage

    The recommended dosages for IMFINZI as a single agent and IMFINZI in combination with other therapeutic agents are presented in Table 1. The recommended dosage schedule and regimens for IMFINZI for the treatment of metastatic NSCLC are provided in Tables 2 and 3

    [see Indications and Usage (1.1)].

    Administer IMFINZI as a 60 minute intravenous infusion after dilution

    [ see Dosage and Administration (2.3)].

    Table 1. Recommended Dosages of IMFINZI
    Indication
    Recommended IMFINZI Dosage
    Duration of Therapy
    Neoadjuvant and Adjuvant Treatment of Resectable NSCLC
    Patients with a body weight of ≥ 30 kg:


    Neoadjuvant: IMFINZI 1,500 mg in combination with chemotherapy
    Administer IMFINZI prior to chemotherapy on the same day. Refer to the Prescribing Information for the agent administered in combination with IMFINZI for recommended dosage information, as appropriate.
    every 3 weeks for up to 4 cycles prior to surgery


    Adjuvant: IMFINZI 1,500 mg as a single agent every 4 weeks for up to 12 cycles after surgery.


    Patients with a body weight of < 30 kg:

    Neoadjuvant: IMFINZI 20 mg/kg every 3 weeks in combination with chemotherapy
    for up to 4 cycles prior to surgery.

    Adjuvant: IMFINZI 20 mg/kg every 4 weeks for up to 12 cycles as a single agent after surgery.
    Until disease progression that precludes definitive surgery, recurrence, unacceptable toxicity, or a maximum of 12 cycles after surgery
    Unresectable Stage III NSCLCFollowing concurrent platinum-based chemotherapy and radiation therapy:

    Patients with a body weight of ≥ 30 kg:

    10 mg/kg every 2 weeks

    or

    1,500 mg every 4 weeks

    Patients with a body weight of < 30 kg:

    10 mg/kg every 2 weeks    		Until disease progression, unacceptable toxicity, or a maximum of 12 months
    Limited Stage SCLCFollowing concurrent platinum-based chemotherapy and radiation therapy:

    Patients with a body weight of ≥ 30 kg:

    1,500 mg every 4 weeks


    Patients with a body weight of < 30 kg:

    20 mg/kg every 4 weeks
    		Until disease progression, unacceptable toxicity, or a maximum of 24 months
    Extensive Stage SCLCPatients with a body weight of ≥ 30 kg:

    1,500 mg in combination with chemotherapy
    every 3 weeks (21 days) for 4 cycles, followed by 1,500 mg every 4 weeks as a single agent

    Patients with a body weight of < 30 kg:

    20 mg/kg in combination with chemotherapy
    every 3 weeks (21 days) for 4 cycles, followed by 10 mg/kg every 2 weeks as a single agent    		Until disease progression or until unacceptable toxicity
    BTCPatients with a body weight of ≥ 30 kg:

    1,500 mg in combination with chemotherapy
    every 3 weeks (21 days) up to 8 cycles followed by 1,500 mg every 4 weeks as a single agent

    Patients with a body weight of < 30 kg:

    20 mg/kg in combination with chemotherapy
    every 3 weeks (21 days) up to 8 cycles, followed by 20 mg/kg every 4 weeks as a single agent    		Until disease progression or until unacceptable toxicity
    uHCCPatients with a body weight of ≥ 30 kg:

    IMFINZI 1,500 mg following a single dose of tremelimumab-actlAdminister tremelimumab-actl prior to IMFINZI on the same day. When tremelimumab-actl is administered in combination with IMFINZI, refer to the Prescribing Information for tremelimumab-actl dosing information.300 mg at Day 1 of Cycle 1;

    Continue IMFINZI 1,500 mg as a single agent every 4 weeks

    Patients with a body weight of < 30 kg:

    IMFINZI 20 mg/kg following a single dose of tremelimumab-actl
    4 mg/kg at Day 1 of Cycle 1;

    Continue IMFINZI 20 mg/kg as a single agent every 4 weeks    		After Cycle 1 of combination therapy, administer IMFINZI as a single agent every 4 weeks until disease progression or unacceptable toxicity
    dMMR endometrial cancer
    Patients with a body weight of ≥ 30 kg:


    IMFINZI 1,120 mg in combination with carboplatin and paclitaxel
    every 3 weeks (21 days) for 6 cycles, followed by IMFINZI 1,500 mg every 4 weeks as a single agent


    Patients with a body weight of < 30 kg:


    IMFINZI 15 mg/kg in combination with carboplatin and paclitaxel
    every 3 weeks (21 days) for 6 cycles, followed by IMFINZI 20 mg/kg every 4 weeks as a single agent
    Until disease progression or unacceptable toxicity
    Neoadjuvant and Adjuvant Treatment of MIBC
    Patients with a body weight of ≥30 kg:


    Neoadjuvant: 1,500 mg in combination with gemcitabine and cisplatin
    every 3 weeks for 4 cycles prior to surgery


    Adjuvant: IMFINZI 1,500 mg as a single agent every 4 weeks for up to 8 cycles after surgery


    Patients with a body weight of < 30 kg:


    Neoadjuvant: 20 mg/kg in combination with gemcitabine and cisplatin
    every 3 weeks for 4 cycles prior to surgery


    Adjuvant: IMFINZI 20 mg/kg as a single agent every 4 weeks for up to 8 cycles after surgery
    Until disease progression that precludes definitive surgery, recurrence, or unacceptable toxicity or a maximum of 8 cycles after surgery
    Neoadjuvant and Adjuvant


    Treatment of Resectable


    GC/GEJC
    Patients with a body weight of ≥ 30


    kg:


    Neoadjuvant: IMFINZI 1,500 mg every 4 weeks with FLOT
    FLOT chemotherapy is administered on days 1 and 15 of each 4 week cycle
    [See Clinical Studies ]
    .
    for up to 2 cycles prior to surgery


    Adjuvant: IMFINZI 1,500 mg every 4 weeks with FLOT
    for up to 2 cycles, followed by IMFINZI 1,500 mg as a single agent every 4 weeks for up to 10 cycles


    Patients with a body weight of < 30 kg:


    Neoadjuvant: IMFINZI 20 mg/kg every 4 weeks with FLOT*± for up to 2 cycles prior to surgery


    Adjuvant: IMFINZI 20 mg/kg every 4 weeks with FLOT
    for up to 2 cycles, followed by IMFINZI 20 mg/kg as a single agent every 4 weeks for up to 10 cycles
    Neoadjuvant: Until disease progression that precludes definitive surgery or unacceptable toxicity

    IMFINZI in Combination with Tremelimumab-actl and Platinum-Based Chemotherapy

    The recommended dosage schedule and regimens for IMFINZI for the treatment of metastatic NSCLC are provided in Tables 2 and 3.

    Weigh patients prior to each infusion.

    Calculate the appropriate dose using Table 3 below based on the patient’s weight and tumor histology.

    Table 2. Recommended Dosage Schedule for Metastatic NSCLC
    Week
    continue IMFINZI until disease progression or intolerable toxicity.note the dosing interval change from every 3 weeks to every 4 weeks starting at cycle 5.
    0123456789101112131415161718192021222324
    Cycle:
    		12345678

    IMFINZI

    intravenous infusion over 60 minutes
    [see
    Dosage and Administration (2.4)
    ]
    .

    X

    X

    X

    X

    X

    X

    X

    X

    Tremelimumab-actl

    if patients receive fewer than 4 cycles of platinum-based chemotherapy, the remaining cycles of tremelimumab-actl (up to a total of 5) should be given after the platinum-based chemotherapy phase, in combination with IMFINZI, every 4 weeks.

    X

    X

    X

    X

    X

    Chemotherapy

    X

    X

    X

    X

    Xoptional pemetrexed therapy from week 12 until disease progression or intolerable toxicity for patients with non-squamous disease who received treatment with pemetrexed and carboplatin/cisplatin.

    X

    X

    X


    OR




    OR



    Table 3. Recommended Regimen and Dosage for Metastatic NSCLC
    Tumor Histology
    Patient Weight
    IMFINZI Dosage
    Tremelimumab-actl DosageRefer to the Prescribing Information for dosing information.
    Platinum-based Chemotherapy Regimen

    Non-Squamous

    ≥ 30 kg

    1,500 mg

    75 mg


    ••

    < 30 kg

    20 mg/kg

    1 mg/kg

    Squamous

    ≥ 30 kg

    1,500 mg

    75 mg


    ••

    < 30 kg

    20 mg/kg

    1 mg/kg

    carboplatin & nab-paclitaxelcarboplatin or cisplatin & pemetrexedcarboplatin & nab-paclitaxelcarboplatin or cisplatin & gemcitabine
    )


    Neoadjuvant:
    IMFINZI 20 mg/kg in combination with gemcitabine and cisplatin every 3 weeks for 4 cycles prior to surgery.

    Adjuvant:
    IMFINZI 20 mg/kg every 4 weeks as a single agent for up to 8 cycles after surgery. (
    2.2 Recommended Dosage

    The recommended dosages for IMFINZI as a single agent and IMFINZI in combination with other therapeutic agents are presented in Table 1. The recommended dosage schedule and regimens for IMFINZI for the treatment of metastatic NSCLC are provided in Tables 2 and 3

    [see Indications and Usage (1.1)].

    Administer IMFINZI as a 60 minute intravenous infusion after dilution

    [ see Dosage and Administration (2.3)].

    Table 1. Recommended Dosages of IMFINZI
    Indication
    Recommended IMFINZI Dosage
    Duration of Therapy
    Neoadjuvant and Adjuvant Treatment of Resectable NSCLC
    Patients with a body weight of ≥ 30 kg:


    Neoadjuvant: IMFINZI 1,500 mg in combination with chemotherapy
    Administer IMFINZI prior to chemotherapy on the same day. Refer to the Prescribing Information for the agent administered in combination with IMFINZI for recommended dosage information, as appropriate.
    every 3 weeks for up to 4 cycles prior to surgery


    Adjuvant: IMFINZI 1,500 mg as a single agent every 4 weeks for up to 12 cycles after surgery.


    Patients with a body weight of < 30 kg:

    Neoadjuvant: IMFINZI 20 mg/kg every 3 weeks in combination with chemotherapy
    for up to 4 cycles prior to surgery.

    Adjuvant: IMFINZI 20 mg/kg every 4 weeks for up to 12 cycles as a single agent after surgery.
    Until disease progression that precludes definitive surgery, recurrence, unacceptable toxicity, or a maximum of 12 cycles after surgery
    Unresectable Stage III NSCLCFollowing concurrent platinum-based chemotherapy and radiation therapy:

    Patients with a body weight of ≥ 30 kg:

    10 mg/kg every 2 weeks

    or

    1,500 mg every 4 weeks

    Patients with a body weight of < 30 kg:

    10 mg/kg every 2 weeks    		Until disease progression, unacceptable toxicity, or a maximum of 12 months
    Limited Stage SCLCFollowing concurrent platinum-based chemotherapy and radiation therapy:

    Patients with a body weight of ≥ 30 kg:

    1,500 mg every 4 weeks


    Patients with a body weight of < 30 kg:

    20 mg/kg every 4 weeks
    		Until disease progression, unacceptable toxicity, or a maximum of 24 months
    Extensive Stage SCLCPatients with a body weight of ≥ 30 kg:

    1,500 mg in combination with chemotherapy
    every 3 weeks (21 days) for 4 cycles, followed by 1,500 mg every 4 weeks as a single agent

    Patients with a body weight of < 30 kg:

    20 mg/kg in combination with chemotherapy
    every 3 weeks (21 days) for 4 cycles, followed by 10 mg/kg every 2 weeks as a single agent    		Until disease progression or until unacceptable toxicity
    BTCPatients with a body weight of ≥ 30 kg:

    1,500 mg in combination with chemotherapy
    every 3 weeks (21 days) up to 8 cycles followed by 1,500 mg every 4 weeks as a single agent

    Patients with a body weight of < 30 kg:

    20 mg/kg in combination with chemotherapy
    every 3 weeks (21 days) up to 8 cycles, followed by 20 mg/kg every 4 weeks as a single agent    		Until disease progression or until unacceptable toxicity
    uHCCPatients with a body weight of ≥ 30 kg:

    IMFINZI 1,500 mg following a single dose of tremelimumab-actlAdminister tremelimumab-actl prior to IMFINZI on the same day. When tremelimumab-actl is administered in combination with IMFINZI, refer to the Prescribing Information for tremelimumab-actl dosing information.300 mg at Day 1 of Cycle 1;

    Continue IMFINZI 1,500 mg as a single agent every 4 weeks

    Patients with a body weight of < 30 kg:

    IMFINZI 20 mg/kg following a single dose of tremelimumab-actl
    4 mg/kg at Day 1 of Cycle 1;

    Continue IMFINZI 20 mg/kg as a single agent every 4 weeks    		After Cycle 1 of combination therapy, administer IMFINZI as a single agent every 4 weeks until disease progression or unacceptable toxicity
    dMMR endometrial cancer
    Patients with a body weight of ≥ 30 kg:


    IMFINZI 1,120 mg in combination with carboplatin and paclitaxel
    every 3 weeks (21 days) for 6 cycles, followed by IMFINZI 1,500 mg every 4 weeks as a single agent


    Patients with a body weight of < 30 kg:


    IMFINZI 15 mg/kg in combination with carboplatin and paclitaxel
    every 3 weeks (21 days) for 6 cycles, followed by IMFINZI 20 mg/kg every 4 weeks as a single agent
    Until disease progression or unacceptable toxicity
    Neoadjuvant and Adjuvant Treatment of MIBC
    Patients with a body weight of ≥30 kg:


    Neoadjuvant: 1,500 mg in combination with gemcitabine and cisplatin
    every 3 weeks for 4 cycles prior to surgery


    Adjuvant: IMFINZI 1,500 mg as a single agent every 4 weeks for up to 8 cycles after surgery


    Patients with a body weight of < 30 kg:


    Neoadjuvant: 20 mg/kg in combination with gemcitabine and cisplatin
    every 3 weeks for 4 cycles prior to surgery


    Adjuvant: IMFINZI 20 mg/kg as a single agent every 4 weeks for up to 8 cycles after surgery
    Until disease progression that precludes definitive surgery, recurrence, or unacceptable toxicity or a maximum of 8 cycles after surgery
    Neoadjuvant and Adjuvant


    Treatment of Resectable


    GC/GEJC
    Patients with a body weight of ≥ 30


    kg:


    Neoadjuvant: IMFINZI 1,500 mg every 4 weeks with FLOT
    FLOT chemotherapy is administered on days 1 and 15 of each 4 week cycle
    [See Clinical Studies ]
    .
    for up to 2 cycles prior to surgery


    Adjuvant: IMFINZI 1,500 mg every 4 weeks with FLOT
    for up to 2 cycles, followed by IMFINZI 1,500 mg as a single agent every 4 weeks for up to 10 cycles


    Patients with a body weight of < 30 kg:


    Neoadjuvant: IMFINZI 20 mg/kg every 4 weeks with FLOT*± for up to 2 cycles prior to surgery


    Adjuvant: IMFINZI 20 mg/kg every 4 weeks with FLOT
    for up to 2 cycles, followed by IMFINZI 20 mg/kg as a single agent every 4 weeks for up to 10 cycles
    Neoadjuvant: Until disease progression that precludes definitive surgery or unacceptable toxicity

    IMFINZI in Combination with Tremelimumab-actl and Platinum-Based Chemotherapy

    The recommended dosage schedule and regimens for IMFINZI for the treatment of metastatic NSCLC are provided in Tables 2 and 3.

    Weigh patients prior to each infusion.

    Calculate the appropriate dose using Table 3 below based on the patient’s weight and tumor histology.

    Table 2. Recommended Dosage Schedule for Metastatic NSCLC
    Week
    continue IMFINZI until disease progression or intolerable toxicity.note the dosing interval change from every 3 weeks to every 4 weeks starting at cycle 5.
    0123456789101112131415161718192021222324
    Cycle:
    		12345678

    IMFINZI

    intravenous infusion over 60 minutes
    [see
    Dosage and Administration (2.4)
    ]
    .

    X

    X

    X

    X

    X

    X

    X

    X

    Tremelimumab-actl

    if patients receive fewer than 4 cycles of platinum-based chemotherapy, the remaining cycles of tremelimumab-actl (up to a total of 5) should be given after the platinum-based chemotherapy phase, in combination with IMFINZI, every 4 weeks.

    X

    X

    X

    X

    X

    Chemotherapy

    X

    X

    X

    X

    Xoptional pemetrexed therapy from week 12 until disease progression or intolerable toxicity for patients with non-squamous disease who received treatment with pemetrexed and carboplatin/cisplatin.

    X

    X

    X


    OR




    OR



    Table 3. Recommended Regimen and Dosage for Metastatic NSCLC
    Tumor Histology
    Patient Weight
    IMFINZI Dosage
    Tremelimumab-actl DosageRefer to the Prescribing Information for dosing information.
    Platinum-based Chemotherapy Regimen

    Non-Squamous

    ≥ 30 kg

    1,500 mg

    75 mg


    ••

    < 30 kg

    20 mg/kg

    1 mg/kg

    Squamous

    ≥ 30 kg

    1,500 mg

    75 mg


    ••

    < 30 kg

    20 mg/kg

    1 mg/kg

    carboplatin & nab-paclitaxelcarboplatin or cisplatin & pemetrexedcarboplatin & nab-paclitaxelcarboplatin or cisplatin & gemcitabine
    )


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    Imfinzi prescribing information

    Indications and Usage (

    1.1 Non-Small Cell Lung Cancer
    • •
      IMFINZI in combination with platinum-containing chemotherapy as neoadjuvant treatment, followed by IMFINZI continued as a single agent as adjuvant treatment after surgery, is indicated for the treatment of adult patients with resectable (tumors ≥ 4 cm and/or node positive) non-small cell lung cancer (NSCLC) and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements.
    • •IMFINZI, as a single agent, is indicated for the treatment of adult patients with unresectable Stage III NSCLC whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy (cCRT).
    • •IMFINZI, in combination with tremelimumab-actl and platinum-based chemotherapy, is indicated for the treatment of adult patients with metastatic NSCLC with no sensitizing EGFR mutations or ALK genomic tumor aberrations.
    ,
    1.2 Small Cell Lung Cancer
    • •
      IMFINZI, as a single agent, is indicated for the treatment of adult patients with limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy (cCRT).
    • •IMFINZI, in combination with etoposide and either carboplatin or cisplatin, is indicated for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC).
    )                                                            12/2024

    Indications and Usage (

    1.5 Endometrial Cancer

    IMFINZI, in combination with carboplatin and paclitaxel followed by IMFINZI as a single agent, is indicated for the treatment of adult patients with primary advanced or recurrent endometrial cancer that is mismatch repair deficient (dMMR) as determined by an FDA-approved test [see Dosage and Administration (2.1)].

    )                                                                    02/2025

    Indications and Usage (

    1.6 Bladder Cancer

    IMFINZI in combination with gemcitabine and cisplatin as neoadjuvant treatment, followed by single agent IMFINZI as adjuvant treatment following radical cystectomy, is indicated for the treatment of adult patients with muscle invasive bladder cancer (MIBC).

    )                                                                    03/2025

    Indications and Usage                                                                      11/2025

    Dosage and Administration (

    2.1 Patient Selection

    Advanced or Recurrent dMMR Endometrial Cancer

    Select patients for treatment based on the presence of dMMR in tumor specimens
    [see Clinical Studies (14.5)].

    Information on FDA-approved tests for the detection of dMMR status in endometrial cancer is available at
    https://www.fda.gov/companiondiagnostics
    .

    )                                                            02/2025

    Dosage and Administration (

    2.1 Patient Selection

    Advanced or Recurrent dMMR Endometrial Cancer

    Select patients for treatment based on the presence of dMMR in tumor specimens
    [see Clinical Studies (14.5)].

    Information on FDA-approved tests for the detection of dMMR status in endometrial cancer is available at
    https://www.fda.gov/companiondiagnostics
    .

    ,
    2.2 Recommended Dosage

    The recommended dosages for IMFINZI as a single agent and IMFINZI in combination with other therapeutic agents are presented in Table 1. The recommended dosage schedule and regimens for IMFINZI for the treatment of metastatic NSCLC are provided in Tables 2 and 3

    [see Indications and Usage (1.1)].

    Administer IMFINZI as a 60 minute intravenous infusion after dilution

    [ see Dosage and Administration (2.3)].

    Table 1. Recommended Dosages of IMFINZI
    Indication
    Recommended IMFINZI Dosage
    Duration of Therapy
    Neoadjuvant and Adjuvant Treatment of Resectable NSCLC
    Patients with a body weight of ≥ 30 kg:


    Neoadjuvant: IMFINZI 1,500 mg in combination with chemotherapy
    Administer IMFINZI prior to chemotherapy on the same day. Refer to the Prescribing Information for the agent administered in combination with IMFINZI for recommended dosage information, as appropriate.
    every 3 weeks for up to 4 cycles prior to surgery


    Adjuvant: IMFINZI 1,500 mg as a single agent every 4 weeks for up to 12 cycles after surgery.


    Patients with a body weight of < 30 kg:

    Neoadjuvant: IMFINZI 20 mg/kg every 3 weeks in combination with chemotherapy
    for up to 4 cycles prior to surgery.

    Adjuvant: IMFINZI 20 mg/kg every 4 weeks for up to 12 cycles as a single agent after surgery.
    Until disease progression that precludes definitive surgery, recurrence, unacceptable toxicity, or a maximum of 12 cycles after surgery
    Unresectable Stage III NSCLCFollowing concurrent platinum-based chemotherapy and radiation therapy:

    Patients with a body weight of ≥ 30 kg:

    10 mg/kg every 2 weeks

    or

    1,500 mg every 4 weeks

    Patients with a body weight of < 30 kg:

    10 mg/kg every 2 weeks    		Until disease progression, unacceptable toxicity, or a maximum of 12 months
    Limited Stage SCLCFollowing concurrent platinum-based chemotherapy and radiation therapy:

    Patients with a body weight of ≥ 30 kg:

    1,500 mg every 4 weeks


    Patients with a body weight of < 30 kg:

    20 mg/kg every 4 weeks
    		Until disease progression, unacceptable toxicity, or a maximum of 24 months
    Extensive Stage SCLCPatients with a body weight of ≥ 30 kg:

    1,500 mg in combination with chemotherapy
    every 3 weeks (21 days) for 4 cycles, followed by 1,500 mg every 4 weeks as a single agent

    Patients with a body weight of < 30 kg:

    20 mg/kg in combination with chemotherapy
    every 3 weeks (21 days) for 4 cycles, followed by 10 mg/kg every 2 weeks as a single agent    		Until disease progression or until unacceptable toxicity
    BTCPatients with a body weight of ≥ 30 kg:

    1,500 mg in combination with chemotherapy
    every 3 weeks (21 days) up to 8 cycles followed by 1,500 mg every 4 weeks as a single agent

    Patients with a body weight of < 30 kg:

    20 mg/kg in combination with chemotherapy
    every 3 weeks (21 days) up to 8 cycles, followed by 20 mg/kg every 4 weeks as a single agent    		Until disease progression or until unacceptable toxicity
    uHCCPatients with a body weight of ≥ 30 kg:

    IMFINZI 1,500 mg following a single dose of tremelimumab-actlAdminister tremelimumab-actl prior to IMFINZI on the same day. When tremelimumab-actl is administered in combination with IMFINZI, refer to the Prescribing Information for tremelimumab-actl dosing information.300 mg at Day 1 of Cycle 1;

    Continue IMFINZI 1,500 mg as a single agent every 4 weeks

    Patients with a body weight of < 30 kg:

    IMFINZI 20 mg/kg following a single dose of tremelimumab-actl
    4 mg/kg at Day 1 of Cycle 1;

    Continue IMFINZI 20 mg/kg as a single agent every 4 weeks    		After Cycle 1 of combination therapy, administer IMFINZI as a single agent every 4 weeks until disease progression or unacceptable toxicity
    dMMR endometrial cancer
    Patients with a body weight of ≥ 30 kg:


    IMFINZI 1,120 mg in combination with carboplatin and paclitaxel
    every 3 weeks (21 days) for 6 cycles, followed by IMFINZI 1,500 mg every 4 weeks as a single agent


    Patients with a body weight of < 30 kg:


    IMFINZI 15 mg/kg in combination with carboplatin and paclitaxel
    every 3 weeks (21 days) for 6 cycles, followed by IMFINZI 20 mg/kg every 4 weeks as a single agent
    Until disease progression or unacceptable toxicity
    Neoadjuvant and Adjuvant Treatment of MIBC
    Patients with a body weight of ≥30 kg:


    Neoadjuvant: 1,500 mg in combination with gemcitabine and cisplatin
    every 3 weeks for 4 cycles prior to surgery


    Adjuvant: IMFINZI 1,500 mg as a single agent every 4 weeks for up to 8 cycles after surgery


    Patients with a body weight of < 30 kg:


    Neoadjuvant: 20 mg/kg in combination with gemcitabine and cisplatin
    every 3 weeks for 4 cycles prior to surgery


    Adjuvant: IMFINZI 20 mg/kg as a single agent every 4 weeks for up to 8 cycles after surgery
    Until disease progression that precludes definitive surgery, recurrence, or unacceptable toxicity or a maximum of 8 cycles after surgery
    Neoadjuvant and Adjuvant


    Treatment of Resectable


    GC/GEJC
    Patients with a body weight of ≥ 30


    kg:


    Neoadjuvant: IMFINZI 1,500 mg every 4 weeks with FLOT
    FLOT chemotherapy is administered on days 1 and 15 of each 4 week cycle
    [See Clinical Studies ]
    .
    for up to 2 cycles prior to surgery


    Adjuvant: IMFINZI 1,500 mg every 4 weeks with FLOT
    for up to 2 cycles, followed by IMFINZI 1,500 mg as a single agent every 4 weeks for up to 10 cycles


    Patients with a body weight of < 30 kg:


    Neoadjuvant: IMFINZI 20 mg/kg every 4 weeks with FLOT*± for up to 2 cycles prior to surgery


    Adjuvant: IMFINZI 20 mg/kg every 4 weeks with FLOT
    for up to 2 cycles, followed by IMFINZI 20 mg/kg as a single agent every 4 weeks for up to 10 cycles
    Neoadjuvant: Until disease progression that precludes definitive surgery or unacceptable toxicity

    IMFINZI in Combination with Tremelimumab-actl and Platinum-Based Chemotherapy

    The recommended dosage schedule and regimens for IMFINZI for the treatment of metastatic NSCLC are provided in Tables 2 and 3.

    Weigh patients prior to each infusion.

    Calculate the appropriate dose using Table 3 below based on the patient’s weight and tumor histology.

    Table 2. Recommended Dosage Schedule for Metastatic NSCLC
    Week
    continue IMFINZI until disease progression or intolerable toxicity.note the dosing interval change from every 3 weeks to every 4 weeks starting at cycle 5.
    0123456789101112131415161718192021222324
    Cycle:
    		12345678

    IMFINZI

    intravenous infusion over 60 minutes
    [see
    Dosage and Administration (2.4)
    ]
    .

    X

    X

    X

    X

    X

    X

    X

    X

    Tremelimumab-actl

    if patients receive fewer than 4 cycles of platinum-based chemotherapy, the remaining cycles of tremelimumab-actl (up to a total of 5) should be given after the platinum-based chemotherapy phase, in combination with IMFINZI, every 4 weeks.

    X

    X

    X

    X

    X

    Chemotherapy

    X

    X

    X

    X

    Xoptional pemetrexed therapy from week 12 until disease progression or intolerable toxicity for patients with non-squamous disease who received treatment with pemetrexed and carboplatin/cisplatin.

    X

    X

    X

    carboplatin & nab-paclitaxel

    OR

    carboplatin or cisplatin & pemetrexedcarboplatin & nab-paclitaxel

    OR

    carboplatin or cisplatin & gemcitabine
    Table 3. Recommended Regimen and Dosage for Metastatic NSCLC
    Tumor Histology
    Patient Weight
    IMFINZI Dosage
    Tremelimumab-actl DosageRefer to the Prescribing Information for dosing information.
    Platinum-based Chemotherapy Regimen

    Non-Squamous

    ≥ 30 kg

    1,500 mg

    75 mg

    ••

    < 30 kg

    20 mg/kg

    1 mg/kg

    Squamous

    ≥ 30 kg

    1,500 mg

    75 mg

    ••

    < 30 kg

    20 mg/kg

    1 mg/kg

    ,
    2.3 Dosage Modifications for Adverse Reactions

    No dose reduction for IMFINZI is recommended. In general, withhold IMFINZI for severe (Grade 3) immune-mediated adverse reactions. Permanently discontinue IMFINZI for life-threatening (Grade 4) immune-mediated adverse reactions, recurrent severe (Grade 3) immune-mediated reactions that require systemic immunosuppressive treatment, or an inability to reduce corticosteroid dose to 10 mg or less of prednisone or equivalent per day within 12 weeks of initiating corticosteroids.

    Dosage modifications for IMFINZI or IMFINZI in combination with tremelimumab-actl or chemotherapy for adverse reactions that require management different from these general guidelines are summarized in Table 4.

    PneumonitisColitisIntestinal perforationHepatitis with no tumor involvement of the liverHepatitis with tumor involvement of the liverIf AST and ALT are less than or equal to ULN at baseline in patients with liver involvement, withhold or permanently discontinue IMFINZI based on recommendations for hepatitis with no liver involvement.EndocrinopathiesNephritis with Renal DysfunctionExfoliative Dermatologic ConditionsMyocarditisNeurological ToxicitiesInfusion-related reactions
    [see Warnings and Precautions (5.2)]
    Table 4. Recommended Dosage Modifications for Adverse Reactions
    Adverse Reaction
    Severity
    Based on National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.03.
    Dosage Modification

    Immune-Mediated Adverse Reactions
    [see Warnings and Precautions (5.1)]

    Grade 2

    WithholdResume in patients with complete or partial resolution (Grade 0 to 1) after corticosteroid taper. Permanently discontinue if no complete or partial resolution within 12 weeks of initiating corticosteroids or an inability to reduce corticosteroid dose to 10 mg of prednisone or less per day (or equivalent) within 12 weeks of initiating corticosteroids.

    Grade 3 or 4

    Permanently discontinue

    Grade 2

    Withhold

    Grade 3

    Withhold

    or permanently discontinuePermanently discontinue IMFINZI for Grade 3 colitis when administered as part of a tremelimumab-actl containing regimen.

    Grade 4

    Permanently discontinue

    Any grade

    Permanently discontinue

    ALT or AST increases to more than 3 and up to 8 times the ULN

    or

    total bilirubin increases to more than 1.5 and up to 3 times ULN

    Withhold

    ALT or AST increases to more than 8 times ULN

    or

    total bilirubin increases to more than 3 times the ULN

    Permanently discontinue

    AST or ALT is more than 1 and up to 3 times ULN at baseline and increases to more than 5 and up to 10 times ULN

    or

    AST or ALT is more than 3 and up to 5 times ULN at baseline and increases to more than 8 and up to 10 times ULN

    Withhold

    AST or ALT increases to more than 10 times ULN

    or

    total bilirubin increases to more than 3 times ULN

    Permanently discontinue

    Grade 3 or 4

    Withhold until clinically stable or permanently discontinue depending on severity

    Grade 2 or 3 increased blood creatinine

    Withhold

    Grade 4 increased blood creatinine

    Permanently discontinue

    Suspected SJS, TEN, or DRESS

    Withhold

    Confirmed SJS, TEN, or DRESS

    Permanently discontinue

    Grade 2, 3, or 4

    Permanently discontinue

    Grade 2

    Withhold

    Grade 3 or 4

    Permanently discontinue

    Other Adverse Reactions

    Grade 1 or 2

    Interrupt or slow the rate of infusion

    Grade 3 or 4

    Permanently discontinue

    ALT = alanine aminotransferase, AST = aspartate aminotransferase, DRESS = Drug Rash with Eosinophilia and Systemic Symptoms, SJS = Stevens Johnson Syndrome, TEN = toxic epidermal necrolysis, ULN = upper limit normal.

    ,
    2.4 Preparation and Administration

    Preparation

    • •Visually inspect drug product for particulate matter and discoloration prior to administration, whenever solution and container permit. Discard the vial if the solution is cloudy, discolored, or visible particles are observed.
    • •Do not shake the vial.
    • •Withdraw the required volume from the vial(s) of IMFINZI and transfer into an intravenous bag containing 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP. Mix diluted solution by gentle inversion. Do not shake the solution. The final concentration of the diluted solution should be between 1 mg/mL and 15 mg/mL.
    • •Discard partially used or empty vials of IMFINZI.

    Storage of Infusion Solution

    • •IMFINZI does not contain a preservative.
    • •Administer infusion solution immediately once prepared. If the infusion solution is not administered immediately and needs to be stored, the time from preparation until the completion of the infusion should not exceed:
      • ∘28 days in a refrigerator at 2°C to 8°C (36°F to 46°F)
      • ∘8 hours at room temperature up to 25°C (77°F)
    • •Do not freeze.
    • •Do not shake.

    Administration

    • •Administer infusion solution intravenously over 60 minutes through an intravenous line containing a sterile, low-protein binding 0.2 or 0.22 micron in-line filter.
    • •Use separate infusion bags and filters for each drug product.

    IMFINZI in Combination with Other Products

    • •Administer all intravenous drug products as separate infusions.
    • •Do not co-administer other intravenous drugs through the same infusion line.
    • •For platinum-based chemotherapy, refer to Prescribing Information for administration information.
    • •For pemetrexed therapy, refer to Prescribing Information for administration information.

    Combination Regimens: Order of Infusions

    IMFINZI in Combination with Tremelimumab-actl

    • •Infuse tremelimumab-actl first, followed by IMFINZI on the same day of dosing.

    IMFINZI in Combination with Tremelimumab-actl and Platinum-Based Chemotherapy

    • •Infuse tremelimumab-actl first, followed by IMFINZI and then platinum-based chemotherapy on the day of dosing.

    IMFINZI in Combination with Tremelimumab-actl and Pemetrexed Therapy

    • •Infuse tremelimumab-actl first, followed by IMFINZI and then pemetrexed therapy on the day of dosing.

    IMFINZI in Combination with Chemotherapy

    • •
      Infuse IMFINZI first and then chemotherapy on the same day of dosing.

    Combination Regimens: Infusion Instructions

    IMFINZI in Combination with Tremelimumab-actl

    • •Administer tremelimumab-actl over 60 minutes followed by a 60 minute observation period. Then administer IMFINZI as a separate intravenous infusion over 60 minutes.

    IMFINZI in Combination with Tremelimumab-actl and Platinum-Based Chemotherapy/ Pemetrexed Therapy

    Cycle 1

    • •Infuse tremelimumab-actl over 60 minutes. One to two hours after completion of tremelimumab-actl infusion, infuse IMFINZI over 60 minutes. One to two hours after completion of IMFINZI infusion, administer platinum-based chemotherapy.

    Subsequent Cycles

    • •If there are no infusion reactions during cycle 1, subsequent cycles of IMFINZI can be given immediately after tremelimumab-actl. The time between the end of the IMFINZI infusion and the start of chemotherapy can be reduced to 30 minutes.
    )                                       12/2024

    Dosage and Administration (

    2.2 Recommended Dosage

    The recommended dosages for IMFINZI as a single agent and IMFINZI in combination with other therapeutic agents are presented in Table 1. The recommended dosage schedule and regimens for IMFINZI for the treatment of metastatic NSCLC are provided in Tables 2 and 3

    [see Indications and Usage (1.1)].

    Administer IMFINZI as a 60 minute intravenous infusion after dilution

    [ see Dosage and Administration (2.3)].

    Table 1. Recommended Dosages of IMFINZI
    Indication
    Recommended IMFINZI Dosage
    Duration of Therapy
    Neoadjuvant and Adjuvant Treatment of Resectable NSCLC
    Patients with a body weight of ≥ 30 kg:


    Neoadjuvant: IMFINZI 1,500 mg in combination with chemotherapy
    Administer IMFINZI prior to chemotherapy on the same day. Refer to the Prescribing Information for the agent administered in combination with IMFINZI for recommended dosage information, as appropriate.
    every 3 weeks for up to 4 cycles prior to surgery


    Adjuvant: IMFINZI 1,500 mg as a single agent every 4 weeks for up to 12 cycles after surgery.


    Patients with a body weight of < 30 kg:

    Neoadjuvant: IMFINZI 20 mg/kg every 3 weeks in combination with chemotherapy
    for up to 4 cycles prior to surgery.

    Adjuvant: IMFINZI 20 mg/kg every 4 weeks for up to 12 cycles as a single agent after surgery.
    Until disease progression that precludes definitive surgery, recurrence, unacceptable toxicity, or a maximum of 12 cycles after surgery
    Unresectable Stage III NSCLCFollowing concurrent platinum-based chemotherapy and radiation therapy:

    Patients with a body weight of ≥ 30 kg:

    10 mg/kg every 2 weeks

    or

    1,500 mg every 4 weeks

    Patients with a body weight of < 30 kg:

    10 mg/kg every 2 weeks    		Until disease progression, unacceptable toxicity, or a maximum of 12 months
    Limited Stage SCLCFollowing concurrent platinum-based chemotherapy and radiation therapy:

    Patients with a body weight of ≥ 30 kg:

    1,500 mg every 4 weeks


    Patients with a body weight of < 30 kg:

    20 mg/kg every 4 weeks
    		Until disease progression, unacceptable toxicity, or a maximum of 24 months
    Extensive Stage SCLCPatients with a body weight of ≥ 30 kg:

    1,500 mg in combination with chemotherapy
    every 3 weeks (21 days) for 4 cycles, followed by 1,500 mg every 4 weeks as a single agent

    Patients with a body weight of < 30 kg:

    20 mg/kg in combination with chemotherapy
    every 3 weeks (21 days) for 4 cycles, followed by 10 mg/kg every 2 weeks as a single agent    		Until disease progression or until unacceptable toxicity
    BTCPatients with a body weight of ≥ 30 kg:

    1,500 mg in combination with chemotherapy
    every 3 weeks (21 days) up to 8 cycles followed by 1,500 mg every 4 weeks as a single agent

    Patients with a body weight of < 30 kg:

    20 mg/kg in combination with chemotherapy
    every 3 weeks (21 days) up to 8 cycles, followed by 20 mg/kg every 4 weeks as a single agent    		Until disease progression or until unacceptable toxicity
    uHCCPatients with a body weight of ≥ 30 kg:

    IMFINZI 1,500 mg following a single dose of tremelimumab-actlAdminister tremelimumab-actl prior to IMFINZI on the same day. When tremelimumab-actl is administered in combination with IMFINZI, refer to the Prescribing Information for tremelimumab-actl dosing information.300 mg at Day 1 of Cycle 1;

    Continue IMFINZI 1,500 mg as a single agent every 4 weeks

    Patients with a body weight of < 30 kg:

    IMFINZI 20 mg/kg following a single dose of tremelimumab-actl
    4 mg/kg at Day 1 of Cycle 1;

    Continue IMFINZI 20 mg/kg as a single agent every 4 weeks    		After Cycle 1 of combination therapy, administer IMFINZI as a single agent every 4 weeks until disease progression or unacceptable toxicity
    dMMR endometrial cancer
    Patients with a body weight of ≥ 30 kg:


    IMFINZI 1,120 mg in combination with carboplatin and paclitaxel
    every 3 weeks (21 days) for 6 cycles, followed by IMFINZI 1,500 mg every 4 weeks as a single agent


    Patients with a body weight of < 30 kg:


    IMFINZI 15 mg/kg in combination with carboplatin and paclitaxel
    every 3 weeks (21 days) for 6 cycles, followed by IMFINZI 20 mg/kg every 4 weeks as a single agent
    Until disease progression or unacceptable toxicity
    Neoadjuvant and Adjuvant Treatment of MIBC
    Patients with a body weight of ≥30 kg:


    Neoadjuvant: 1,500 mg in combination with gemcitabine and cisplatin
    every 3 weeks for 4 cycles prior to surgery


    Adjuvant: IMFINZI 1,500 mg as a single agent every 4 weeks for up to 8 cycles after surgery


    Patients with a body weight of < 30 kg:


    Neoadjuvant: 20 mg/kg in combination with gemcitabine and cisplatin
    every 3 weeks for 4 cycles prior to surgery


    Adjuvant: IMFINZI 20 mg/kg as a single agent every 4 weeks for up to 8 cycles after surgery
    Until disease progression that precludes definitive surgery, recurrence, or unacceptable toxicity or a maximum of 8 cycles after surgery
    Neoadjuvant and Adjuvant


    Treatment of Resectable


    GC/GEJC
    Patients with a body weight of ≥ 30


    kg:


    Neoadjuvant: IMFINZI 1,500 mg every 4 weeks with FLOT
    FLOT chemotherapy is administered on days 1 and 15 of each 4 week cycle
    [See Clinical Studies ]
    .
    for up to 2 cycles prior to surgery


    Adjuvant: IMFINZI 1,500 mg every 4 weeks with FLOT
    for up to 2 cycles, followed by IMFINZI 1,500 mg as a single agent every 4 weeks for up to 10 cycles


    Patients with a body weight of < 30 kg:


    Neoadjuvant: IMFINZI 20 mg/kg every 4 weeks with FLOT*± for up to 2 cycles prior to surgery


    Adjuvant: IMFINZI 20 mg/kg every 4 weeks with FLOT
    for up to 2 cycles, followed by IMFINZI 20 mg/kg as a single agent every 4 weeks for up to 10 cycles
    Neoadjuvant: Until disease progression that precludes definitive surgery or unacceptable toxicity

    IMFINZI in Combination with Tremelimumab-actl and Platinum-Based Chemotherapy

    The recommended dosage schedule and regimens for IMFINZI for the treatment of metastatic NSCLC are provided in Tables 2 and 3.

    Weigh patients prior to each infusion.

    Calculate the appropriate dose using Table 3 below based on the patient’s weight and tumor histology.

    Table 2. Recommended Dosage Schedule for Metastatic NSCLC
    Week
    continue IMFINZI until disease progression or intolerable toxicity.note the dosing interval change from every 3 weeks to every 4 weeks starting at cycle 5.
    0123456789101112131415161718192021222324
    Cycle:
    		12345678

    IMFINZI

    intravenous infusion over 60 minutes
    [see
    Dosage and Administration (2.4)
    ]
    .

    X

    X

    X

    X

    X

    X

    X

    X

    Tremelimumab-actl

    if patients receive fewer than 4 cycles of platinum-based chemotherapy, the remaining cycles of tremelimumab-actl (up to a total of 5) should be given after the platinum-based chemotherapy phase, in combination with IMFINZI, every 4 weeks.

    X

    X

    X

    X

    X

    Chemotherapy

    X

    X

    X

    X

    Xoptional pemetrexed therapy from week 12 until disease progression or intolerable toxicity for patients with non-squamous disease who received treatment with pemetrexed and carboplatin/cisplatin.

    X

    X

    X

    carboplatin & nab-paclitaxel

    OR

    carboplatin or cisplatin & pemetrexedcarboplatin & nab-paclitaxel

    OR

    carboplatin or cisplatin & gemcitabine
    Table 3. Recommended Regimen and Dosage for Metastatic NSCLC
    Tumor Histology
    Patient Weight
    IMFINZI Dosage
    Tremelimumab-actl DosageRefer to the Prescribing Information for dosing information.
    Platinum-based Chemotherapy Regimen

    Non-Squamous

    ≥ 30 kg

    1,500 mg

    75 mg

    ••

    < 30 kg

    20 mg/kg

    1 mg/kg

    Squamous

    ≥ 30 kg

    1,500 mg

    75 mg

    ••

    < 30 kg

    20 mg/kg

    1 mg/kg

    ,
    2.4 Preparation and Administration

    Preparation

    • •Visually inspect drug product for particulate matter and discoloration prior to administration, whenever solution and container permit. Discard the vial if the solution is cloudy, discolored, or visible particles are observed.
    • •Do not shake the vial.
    • •Withdraw the required volume from the vial(s) of IMFINZI and transfer into an intravenous bag containing 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP. Mix diluted solution by gentle inversion. Do not shake the solution. The final concentration of the diluted solution should be between 1 mg/mL and 15 mg/mL.
    • •Discard partially used or empty vials of IMFINZI.

    Storage of Infusion Solution

    • •IMFINZI does not contain a preservative.
    • •Administer infusion solution immediately once prepared. If the infusion solution is not administered immediately and needs to be stored, the time from preparation until the completion of the infusion should not exceed:
      • ∘28 days in a refrigerator at 2°C to 8°C (36°F to 46°F)
      • ∘8 hours at room temperature up to 25°C (77°F)
    • •Do not freeze.
    • •Do not shake.

    Administration

    • •Administer infusion solution intravenously over 60 minutes through an intravenous line containing a sterile, low-protein binding 0.2 or 0.22 micron in-line filter.
    • •Use separate infusion bags and filters for each drug product.

    IMFINZI in Combination with Other Products

    • •Administer all intravenous drug products as separate infusions.
    • •Do not co-administer other intravenous drugs through the same infusion line.
    • •For platinum-based chemotherapy, refer to Prescribing Information for administration information.
    • •For pemetrexed therapy, refer to Prescribing Information for administration information.

    Combination Regimens: Order of Infusions

    IMFINZI in Combination with Tremelimumab-actl

    • •Infuse tremelimumab-actl first, followed by IMFINZI on the same day of dosing.

    IMFINZI in Combination with Tremelimumab-actl and Platinum-Based Chemotherapy

    • •Infuse tremelimumab-actl first, followed by IMFINZI and then platinum-based chemotherapy on the day of dosing.

    IMFINZI in Combination with Tremelimumab-actl and Pemetrexed Therapy

    • •Infuse tremelimumab-actl first, followed by IMFINZI and then pemetrexed therapy on the day of dosing.

    IMFINZI in Combination with Chemotherapy

    • •
      Infuse IMFINZI first and then chemotherapy on the same day of dosing.

    Combination Regimens: Infusion Instructions

    IMFINZI in Combination with Tremelimumab-actl

    • •Administer tremelimumab-actl over 60 minutes followed by a 60 minute observation period. Then administer IMFINZI as a separate intravenous infusion over 60 minutes.

    IMFINZI in Combination with Tremelimumab-actl and Platinum-Based Chemotherapy/ Pemetrexed Therapy

    Cycle 1

    • •Infuse tremelimumab-actl over 60 minutes. One to two hours after completion of tremelimumab-actl infusion, infuse IMFINZI over 60 minutes. One to two hours after completion of IMFINZI infusion, administer platinum-based chemotherapy.

    Subsequent Cycles

    • •If there are no infusion reactions during cycle 1, subsequent cycles of IMFINZI can be given immediately after tremelimumab-actl. The time between the end of the IMFINZI infusion and the start of chemotherapy can be reduced to 30 minutes.
    )                                                     03/2025

    Dosage and Administration (

    2.2 Recommended Dosage

    The recommended dosages for IMFINZI as a single agent and IMFINZI in combination with other therapeutic agents are presented in Table 1. The recommended dosage schedule and regimens for IMFINZI for the treatment of metastatic NSCLC are provided in Tables 2 and 3

    [see Indications and Usage (1.1)].

    Administer IMFINZI as a 60 minute intravenous infusion after dilution

    [ see Dosage and Administration (2.3)].

    Table 1. Recommended Dosages of IMFINZI
    Indication
    Recommended IMFINZI Dosage
    Duration of Therapy
    Neoadjuvant and Adjuvant Treatment of Resectable NSCLC
    Patients with a body weight of ≥ 30 kg:


    Neoadjuvant: IMFINZI 1,500 mg in combination with chemotherapy
    Administer IMFINZI prior to chemotherapy on the same day. Refer to the Prescribing Information for the agent administered in combination with IMFINZI for recommended dosage information, as appropriate.
    every 3 weeks for up to 4 cycles prior to surgery


    Adjuvant: IMFINZI 1,500 mg as a single agent every 4 weeks for up to 12 cycles after surgery.


    Patients with a body weight of < 30 kg:

    Neoadjuvant: IMFINZI 20 mg/kg every 3 weeks in combination with chemotherapy
    for up to 4 cycles prior to surgery.

    Adjuvant: IMFINZI 20 mg/kg every 4 weeks for up to 12 cycles as a single agent after surgery.
    Until disease progression that precludes definitive surgery, recurrence, unacceptable toxicity, or a maximum of 12 cycles after surgery
    Unresectable Stage III NSCLCFollowing concurrent platinum-based chemotherapy and radiation therapy:

    Patients with a body weight of ≥ 30 kg:

    10 mg/kg every 2 weeks

    or

    1,500 mg every 4 weeks

    Patients with a body weight of < 30 kg:

    10 mg/kg every 2 weeks    		Until disease progression, unacceptable toxicity, or a maximum of 12 months
    Limited Stage SCLCFollowing concurrent platinum-based chemotherapy and radiation therapy:

    Patients with a body weight of ≥ 30 kg:

    1,500 mg every 4 weeks


    Patients with a body weight of < 30 kg:

    20 mg/kg every 4 weeks
    		Until disease progression, unacceptable toxicity, or a maximum of 24 months
    Extensive Stage SCLCPatients with a body weight of ≥ 30 kg:

    1,500 mg in combination with chemotherapy
    every 3 weeks (21 days) for 4 cycles, followed by 1,500 mg every 4 weeks as a single agent

    Patients with a body weight of < 30 kg:

    20 mg/kg in combination with chemotherapy
    every 3 weeks (21 days) for 4 cycles, followed by 10 mg/kg every 2 weeks as a single agent    		Until disease progression or until unacceptable toxicity
    BTCPatients with a body weight of ≥ 30 kg:

    1,500 mg in combination with chemotherapy
    every 3 weeks (21 days) up to 8 cycles followed by 1,500 mg every 4 weeks as a single agent

    Patients with a body weight of < 30 kg:

    20 mg/kg in combination with chemotherapy
    every 3 weeks (21 days) up to 8 cycles, followed by 20 mg/kg every 4 weeks as a single agent    		Until disease progression or until unacceptable toxicity
    uHCCPatients with a body weight of ≥ 30 kg:

    IMFINZI 1,500 mg following a single dose of tremelimumab-actlAdminister tremelimumab-actl prior to IMFINZI on the same day. When tremelimumab-actl is administered in combination with IMFINZI, refer to the Prescribing Information for tremelimumab-actl dosing information.300 mg at Day 1 of Cycle 1;

    Continue IMFINZI 1,500 mg as a single agent every 4 weeks

    Patients with a body weight of < 30 kg:

    IMFINZI 20 mg/kg following a single dose of tremelimumab-actl
    4 mg/kg at Day 1 of Cycle 1;

    Continue IMFINZI 20 mg/kg as a single agent every 4 weeks    		After Cycle 1 of combination therapy, administer IMFINZI as a single agent every 4 weeks until disease progression or unacceptable toxicity
    dMMR endometrial cancer
    Patients with a body weight of ≥ 30 kg:


    IMFINZI 1,120 mg in combination with carboplatin and paclitaxel
    every 3 weeks (21 days) for 6 cycles, followed by IMFINZI 1,500 mg every 4 weeks as a single agent


    Patients with a body weight of < 30 kg:


    IMFINZI 15 mg/kg in combination with carboplatin and paclitaxel
    every 3 weeks (21 days) for 6 cycles, followed by IMFINZI 20 mg/kg every 4 weeks as a single agent
    Until disease progression or unacceptable toxicity
    Neoadjuvant and Adjuvant Treatment of MIBC
    Patients with a body weight of ≥30 kg:


    Neoadjuvant: 1,500 mg in combination with gemcitabine and cisplatin
    every 3 weeks for 4 cycles prior to surgery


    Adjuvant: IMFINZI 1,500 mg as a single agent every 4 weeks for up to 8 cycles after surgery


    Patients with a body weight of < 30 kg:


    Neoadjuvant: 20 mg/kg in combination with gemcitabine and cisplatin
    every 3 weeks for 4 cycles prior to surgery


    Adjuvant: IMFINZI 20 mg/kg as a single agent every 4 weeks for up to 8 cycles after surgery
    Until disease progression that precludes definitive surgery, recurrence, or unacceptable toxicity or a maximum of 8 cycles after surgery
    Neoadjuvant and Adjuvant


    Treatment of Resectable


    GC/GEJC
    Patients with a body weight of ≥ 30


    kg:


    Neoadjuvant: IMFINZI 1,500 mg every 4 weeks with FLOT
    FLOT chemotherapy is administered on days 1 and 15 of each 4 week cycle
    [See Clinical Studies ]
    .
    for up to 2 cycles prior to surgery


    Adjuvant: IMFINZI 1,500 mg every 4 weeks with FLOT
    for up to 2 cycles, followed by IMFINZI 1,500 mg as a single agent every 4 weeks for up to 10 cycles


    Patients with a body weight of < 30 kg:


    Neoadjuvant: IMFINZI 20 mg/kg every 4 weeks with FLOT*± for up to 2 cycles prior to surgery


    Adjuvant: IMFINZI 20 mg/kg every 4 weeks with FLOT
    for up to 2 cycles, followed by IMFINZI 20 mg/kg as a single agent every 4 weeks for up to 10 cycles
    Neoadjuvant: Until disease progression that precludes definitive surgery or unacceptable toxicity

    IMFINZI in Combination with Tremelimumab-actl and Platinum-Based Chemotherapy

    The recommended dosage schedule and regimens for IMFINZI for the treatment of metastatic NSCLC are provided in Tables 2 and 3.

    Weigh patients prior to each infusion.

    Calculate the appropriate dose using Table 3 below based on the patient’s weight and tumor histology.

    Table 2. Recommended Dosage Schedule for Metastatic NSCLC
    Week
    continue IMFINZI until disease progression or intolerable toxicity.note the dosing interval change from every 3 weeks to every 4 weeks starting at cycle 5.
    0123456789101112131415161718192021222324
    Cycle:
    		12345678

    IMFINZI

    intravenous infusion over 60 minutes
    [see
    Dosage and Administration (2.4)
    ]
    .

    X

    X

    X

    X

    X

    X

    X

    X

    Tremelimumab-actl

    if patients receive fewer than 4 cycles of platinum-based chemotherapy, the remaining cycles of tremelimumab-actl (up to a total of 5) should be given after the platinum-based chemotherapy phase, in combination with IMFINZI, every 4 weeks.

    X

    X

    X

    X

    X

    Chemotherapy

    X

    X

    X

    X

    Xoptional pemetrexed therapy from week 12 until disease progression or intolerable toxicity for patients with non-squamous disease who received treatment with pemetrexed and carboplatin/cisplatin.

    X

    X

    X

    carboplatin & nab-paclitaxel

    OR

    carboplatin or cisplatin & pemetrexedcarboplatin & nab-paclitaxel

    OR

    carboplatin or cisplatin & gemcitabine
    Table 3. Recommended Regimen and Dosage for Metastatic NSCLC
    Tumor Histology
    Patient Weight
    IMFINZI Dosage
    Tremelimumab-actl DosageRefer to the Prescribing Information for dosing information.
    Platinum-based Chemotherapy Regimen

    Non-Squamous

    ≥ 30 kg

    1,500 mg

    75 mg

    ••

    < 30 kg

    20 mg/kg

    1 mg/kg

    Squamous

    ≥ 30 kg

    1,500 mg

    75 mg

    ••

    < 30 kg

    20 mg/kg

    1 mg/kg

    )                                                           11/2025

    Warnings and Precautions (

    5.1 Immune-Mediated Adverse Reactions

    IMFINZI is a monoclonal antibody that belongs to a class of drugs that bind to either the programmed death-receptor 1 (PD-1) or the PD-ligand 1 (PD-L1), blocking the PD-1/PD-L1 pathway, thereby removing inhibition of the immune response, potentially breaking peripheral tolerance and inducing immune-mediated adverse reactions. Important immune-mediated adverse reactions listed under Warnings and Precautions may not include all possible severe and fatal immune-mediated reactions.

    The incidence and severity of immune-mediated adverse reactions were similar when IMFINZI was administered as a single agent or in combination with chemotherapy or in combination with tremelimumab-actl and platinum-based chemotherapy, unless otherwise noted.

    Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue. Immune-mediated adverse reactions can occur at any time after starting treatment with a PD 1/PD L1 blocking antibody. While immune-mediated adverse reactions usually manifest during treatment with PD-1/PD-L1 blocking antibodies, immune-mediated adverse reactions can also manifest after discontinuation of PD-1/PD-L1 blocking antibodies.

    Early identification and management of immune-mediated adverse reactions are essential to ensure safe use of PD-1/PD-L1 blocking antibodies. Monitor patients closely for symptoms and signs that may be clinical manifestations of underlying immune-mediated adverse reactions. Evaluate liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment. In cases of suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection. Institute medical management promptly, including specialty consultation as appropriate.

    Withhold or permanently discontinue IMFINZI depending on severity

    [see
    Dosage and Administration (2.3)
    ]
    . In general, if IMFINZI requires interruption or discontinuation, administer systemic corticosteroid therapy (1 mg to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Consider administration of other systemic immunosuppressants in patients whose immune-mediated adverse reactions are not controlled with corticosteroid therapy.

    Toxicity management guidelines for adverse reactions that do not necessarily require systemic steroids (e.g., endocrinopathies and dermatologic reactions) are discussed below.

    Immune-Mediated Pneumonitis

    IMFINZI can cause immune-mediated pneumonitis. The incidence of pneumonitis is higher in patients who have received prior thoracic radiation.

    IMFINZI as a Single Agent

    In Patients Who Did Not Receive Recent Prior Radiation

    In patients who received IMFINZI on clinical studies in which radiation therapy was generally not administered immediately prior to initiation of IMFINZI, the incidence of immune-mediated pneumonitis was 2.4% (34/1414), including fatal (< 0.1%), and Grade 3-4 (0.4%) adverse reactions. Events resolved in 19 of the 34 patients and resulted in permanent discontinuation in 5 patients. Systemic corticosteroids were required in 19 patients (19/34) with pneumonitis who did not receive chemoradiation prior to initiation of IMFINZI.

    The frequency and severity of immune-mediated pneumonitis in patients who did not receive definitive chemoradiation prior to IMFINZI were similar whether IMFINZI was given as a single agent in patients with various cancers in a pooled data set or in patients with ES-SCLC or BTC when given in combination with chemotherapy.

    In Patients Who Received Recent Prior Radiation

    The incidence of pneumonitis (including radiation pneumonitis) in patients with unresectable Stage III NSCLC following definitive chemoradiation within 42 days prior to initiation of IMFINZI in PACIFIC was 18.3% (87/475) in patients receiving IMFINZI and 12.8% (30/234) in patients receiving placebo. Of the patients who received IMFINZI (475), 1.1% had a fatal adverse reaction and 2.7% had Grade 3 adverse reactions. Events resolved in 50 of the 87 (57%) patients and resulted in permanent discontinuation in 27 of the 87 (31%) patients. Systemic corticosteroids were required in 64 patients (64/87) with pneumonitis who had received chemoradiation prior to initiation of IMFINZI, while 2 patients required use of infliximab with high-dose steroids.

    The incidence of pneumonitis (including radiation pneumonitis) in patients with LS-SCLC following chemoradiation within 42 days prior to initiation of IMFINZI in ADRIATIC was 14% (37/262) in patients receiving IMFINZI and 6% (16/265) in patients receiving placebo. Of the patients who received IMFINZI (262), 0.4% had a fatal adverse reaction and 2.7% had Grade 3 adverse reactions. Events resolved in 19 of the 37 (51%) patients and resulted in permanent discontinuation in 18 of the 37 (49%) patients. Systemic corticosteroids were required in all patients, while 1 patient required use of infliximab with high-dose steroids
    .

    IMFINZI with Tremelimumab-actl

    Immune-mediated pneumonitis occurred in 1.3% (5/388) of patients receiving IMFINZI in combination with tremelimumab-actl, including fatal (0.3%) and Grade 3 (0.2%) adverse reactions. Events resolved in 3 of the 5 patients and resulted in permanent discontinuation in 1 patient. Systemic corticosteroids were required in all patients; of these, 4 patients required high-dose corticosteroid treatment (at least 40 mg prednisone or equivalent per day). One patient (1/5) required other immunosuppressants.

    IMFINZI with Tremelimumab-actl and Platinum-Based Chemotherapy

    Immune-mediated pneumonitis occurred in 3.5% (21/596) of patients receiving IMFINZI in combination with tremelimumab-actl and platinum-based chemotherapy, including fatal (0.5%), and Grade 3 (1%) adverse reactions. Events resolved in 11 of the 21 patients and resulted in permanent discontinuation in 7 patients. Systemic corticosteroids were required in all patients with immune-mediated pneumonitis, while 1 patient (1/21) required other immunosuppressants.

    Immune-Mediated Colitis

    IMFINZI can cause immune-mediated colitis that is frequently associated with diarrhea. Cytomegalovirus (CMV) infection/reactivation has been reported in patients with corticosteroid-refractory immune-mediated colitis. In cases of corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies.

    IMFINZI as a Single Agent

    Immune-mediated colitis occurred in 2% (37/1889) of patients receiving IMFINZI, including Grade 4 (< 0.1%) and Grade 3 (0.4%) adverse reactions. Events resolved in 27 of the 37 patients and resulted in permanent discontinuation in 8 patients. Systemic corticosteroids were required in all patients with immune-mediated colitis, while 2 patients (2/37) required other immunosuppressants (e.g., infliximab, mycophenolate).

    IMFINZI with Tremelimumab-actl

    Immune-mediated colitis or diarrhea occurred in 6% (23/388) of patients receiving IMFINZI in combination with tremelimumab-actl, including Grade 3 (3.6%) adverse reactions. Events resolved in 22 of the 23 patients and resulted in permanent discontinuation in 5 patients. All patients received systemic corticosteroids, and 20 of the 23 patients received high-dose corticosteroid treatment (at least 40 mg prednisone or equivalent per day). Three patients also received other immunosuppressants.

    Intestinal perforation has been observed in other studies of IMFINZI in combination with tremelimumab-actl.

    IMFINZI with Tremelimumab-actl and Platinum-Based Chemotherapy

    Immune-mediated colitis occurred in 6.5% (39/596) of patients receiving IMFINZI in combination with tremelimumab-actl including fatal (0.2%) and Grade 3 (2.5%) adverse reactions. Events resolved in 33 of 39 patients and resulted in permanent discontinuation in 11 patients. Systemic corticosteroids were required in all patients with immune-mediated colitis, while 4 patients (4/39) required other corticosteroids.

    Intestinal perforation and large intestine perforation were reported in 0.1% of patients receiving IMFINZI in combination with tremelimumab-actl.

    Immune-Mediated Hepatitis

    IMFINZI can cause immune-mediated hepatitis.

    IMFINZI as a Single Agent

    Immune-mediated hepatitis occurred in 2.8% (52/1889) of patients receiving IMFINZI, including fatal (0.2%), Grade 4 (0.3%) and Grade 3 (1.4%) adverse reactions. Events resolved in 21 of the 52 patients and resulted in permanent discontinuation of IMFINZI in 6 patients. Systemic corticosteroids were required in all patients with immune-mediated hepatitis, while 2 patients (2/52) required use of mycophenolate with high-dose steroids.

    IMFINZI with Tremelimumab-actl

    Immune-mediated hepatitis occurred in 7.5% (29/388) of patients receiving IMFINZI in combination with tremelimumab-actl, including fatal (0.8%), Grade 4 (0.3%), and Grade 3 (4.1%) adverse reactions. Events resolved in 12 of the 29 patients and resulted in permanent discontinuation in 9 patients. Systemic corticosteroids were required in all 29 patients and all 29 patients required high-dose corticosteroid treatment (at least 40 mg prednisone or equivalent per day). Eight patients (8/29) required other immunosuppressants.

    IMFINZI with Tremelimumab-actl and Platinum-Based Chemotherapy

    Immune-mediated hepatitis occurred in 3.9% (23/596) of patients receiving IMFINZI in combination with tremelimumab-actl, including fatal (0.3%), Grade 4 (0.5%), and Grade 3 (2.0%) adverse reactions. Events resolved in 12 of the 23 patients and resulted in permanent discontinuation in 10 patients. Systemic corticosteroids were required in all patients with immune-mediated hepatitis, while 2 patients (2/23) required use of other immunosuppressants.

    Immune-Mediated Endocrinopathies

    Adrenal Insufficiency

    IMFINZI can cause primary or secondary adrenal insufficiency. For Grade 2 or higher adrenal insufficiency, initiate symptomatic treatment, including hormone replacement as clinically indicated. Withhold or permanently discontinue IMFINZI based on the severity

    [see
    Dosage and Administration (2.3)
    ]
    .

    IMFINZI as a Single Agent

    Immune-mediated adrenal insufficiency occurred in 0.5% (9/1889) of patients receiving IMFINZI, including Grade 3 (< 0.1%) adverse reactions. Events resolved in 1 of the 9 patients and did not lead to permanent discontinuation of IMFINZI in any patients. Systemic corticosteroids were required in all patients with adrenal insufficiency; of these, the majority remained on systemic corticosteroids.

    IMFINZI with Tremelimumab-actl

    Immune-mediated adrenal insufficiency occurred in 1.5% (6/388) of patients receiving IMFINZI in combination with tremelimumab-actl, including Grade 3 (0.3%) adverse reactions. Events resolved in 2 of the 6 patients. Systemic corticosteroids were required in all 6 patients, and of these, 1 patient required high-dose corticosteroid treatment (at least 40 mg prednisone or equivalent per day).

    IMFINZI with Tremelimumab-actl and Platinum-Based Chemotherapy

    Immune-mediated adrenal insufficiency occurred in 2.2% (13/596) of patients receiving IMFINZI in combination with tremelimumab-actl, including Grade 3 (0.8%) adverse reactions. Events resolved in 2 of the 13 patients and resulted in permanent discontinuation in 1 patient. Systemic corticosteroids were required in all patients with adrenal insufficiency. One patient also required endocrine therapy.

    Hypophysitis

    IMFINZI can cause immune-mediated hypophysitis. Hypophysitis can present with acute symptoms associated with mass effect such as headache, photophobia, or visual field cuts. Hypophysitis can cause hypopituitarism. Initiate symptomatic treatment including hormone replacement as clinically indicated. Withhold or permanently discontinue IMFINZI depending on severity

    [see
    Dosage and Administration (2.3)
    ]
    .

    IMFINZI as a Single Agent

    Grade 3 hypophysitis/hypopituitarism occurred in < 0.1% (1/1889) of patients who received IMFINZI. Treatment with systemic corticosteroids was administered in this patient. The event did not lead to permanent discontinuation of IMFINZI.

    IMFINZI with Tremelimumab-actl

    Immune-mediated hypophysitis/hypopituitarism occurred in 1% (4/388) of patients receiving IMFINZI in combination with tremelimumab-actl. Events resolved in 2 of the 4 patients. Systemic corticosteroids were required in 3 patients, and of these, 1 patient received high-dose corticosteroid treatment (at least 40 mg prednisone or equivalent per day). Two patients also required endocrine therapy.

    IMFINZI with Tremelimumab-actl and Platinum-Based Chemotherapy

    Immune-mediated hypophysitis occurred in 1.3% (8/596) of patients receiving IMFINZI in combination with tremelimumab-actl, including Grade 3 (0.5%) adverse reactions. Events resulted in permanent discontinuation in 1 patient. Systemic corticosteroids were required in 6 patients with immune-mediated hypophysitis; of these, 2 of the 8 patients received high-dose corticosteroid treatment (at least 40 mg prednisone or equivalent per day). Four patients also required endocrine therapy.

    Thyroid Disorders

    IMFINZI can cause immune-mediated thyroid disorders. Thyroiditis can present with or without endocrinopathy. Hypothyroidism can follow hyperthyroidism. Initiate hormone replacement therapy for hypothyroidism or institute medical management of hyperthyroidism as clinically indicated. Withhold or discontinue IMFINZI based on the severity

    [see
    Dosage and Administration (2.3)
    ]
    .

    Thyroiditis

    IMFINZI as a Single Agent

    Immune-mediated thyroiditis occurred in 0.5% (9/1889) of patients receiving IMFINZI, including Grade 3 (< 0.1%) adverse reactions. Events resolved in 4 of the 9 patients and resulted in permanent discontinuation in 1 patient. Systemic corticosteroids were required in 3 patients (3/9) with immune-mediated thyroiditis, while 8 patients (8/9) required endocrine therapy.

    IMFINZI with Tremelimumab-actl

    Immune-mediated thyroiditis occurred in 1.5% (6/388) of patients receiving IMFINZI in combination with tremelimumab-actl. Events resolved in 2 of the 6 patients. Systemic corticosteroids were required in 2 patients (2/6) with immune-mediated thyroiditis; of these, 1 patient required high-dose corticosteroid treatment (at least 40 mg prednisone or equivalent per day). All patients required other therapy including hormone replacement therapy, thiamazole, carbimazole, propylthiouracil, perchlorate, calcium channel blocker, or beta-blocker.

    IMFINZI with Tremelimumab-actl and Platinum-Based Chemotherapy

    Immune-mediated thyroiditis occurred in 1.2% (7/596) of patients receiving IMFINZI in combination with tremelimumab-actl. Events resolved in 2 of the 7 patients and one resulted in permanent discontinuation. Systemic corticosteroids were required in 2 patients (2/7) with immune-mediated thyroiditis, while all patients required endocrine therapy.

    Hyperthyroidism

    IMFINZI as a Single Agent

    Immune-mediated hyperthyroidism occurred in 2.1% (39/1889) of patients receiving IMFINZI. Events resolved in 30 of the 39 patients and did not lead to permanent discontinuation of IMFINZI in any patients. Systemic corticosteroids were required in 9 patients (9/39) with immune-mediated hyperthyroidism, while 35 patients (35/39) required endocrine therapy.

    IMFINZI with Tremelimumab-actl

    Immune-mediated hyperthyroidism occurred in 4.6% (18/388) of patients receiving IMFINZI in combination with tremelimumab-actl, including Grade 3 (0.3%) adverse reactions. Events resolved in 15 of the 18 patients. Two patients (2/18) required high-dose corticosteroid treatment (at least 40 mg prednisone or equivalent per day). Seventeen patients required other therapy (thiamazole, carbimazole, propylthiouracil, perchlorate, calcium channel blocker, or beta-blocker).

    IMFINZI with Tremelimumab-actl and Platinum-Based Chemotherapy

    Immune-mediated hyperthyroidism occurred in 5% (30/596) of patients receiving IMFINZI in combination with tremelimumab-actl, including Grade 3 (0.2%) adverse reactions. Events resolved in 21 of the 30 patients. Systemic corticosteroids were required in 5 patients (5/30) with immune-mediated hyperthyroidism, while 28 patients (28/30) required endocrine therapy.

    Hypothyroidism

    IMFINZI as a Single Agent

    Immune-mediated hypothyroidism occurred in 8.3% (156/1889) of patients receiving IMFINZI, including Grade 3 (<0.1%) adverse reactions. Events resolved in 31 of the 156 patients and did not lead to permanent discontinuation of IMFINZI in any patients. Systemic corticosteroids were required in 11 patients (11/156) and the majority of patients (152/156) required long-term thyroid hormone replacement.

    IMFINZI with Tremelimumab-actl

    Immune-mediated hypothyroidism occurred in 11% (42/388) of patients receiving IMFINZI in combination with tremelimumab-actl. Events resolved in 5 of the 42 patients. One patient received high-dose corticosteroid treatment (at least 40 mg prednisone or equivalent per day). All patients required other therapy (thiamazole, carbimazole, propylthiouracil, perchlorate, calcium channel blocker, or beta-blocker).

    IMFINZI with Tremelimumab-actl and Platinum-Based Chemotherapy

    Immune-mediated hypothyroidism occurred in 8.6% (51/596) of patients receiving IMFINZI in combination with tremelimumab-actl, including Grade 3 (0.5%) adverse reactions. Systemic corticosteroids were required in 2 patients (2/51) and all patients required endocrine therapy.

    IMFINZI with Carboplatin and Paclitaxel

    Immune-mediated hypothyroidism occurred in 14% (34/235) of patients receiving IMFINZI in combination with carboplatin and paclitaxel. Events resolved in 8 of the 34 patients. Endocrine therapy was required in 34 of the 34 patients.

    Type 1 Diabetes Mellitus, which can present with diabetic ketoacidosis

    Monitor patients for hyperglycemia or other signs and symptoms of diabetes. Initiate treatment with insulin as clinically indicated. Withhold or permanently discontinue IMFINZI based on the severity

    [see
    Dosage and Administration (2.3)
    ].

    IMFINZI as a Single Agent

    Grade 3 immune-mediated type 1 diabetes mellitus occurred in < 0.1% (1/1889) of patients receiving IMFINZI. This patient required long-term insulin therapy and IMFINZI was permanently discontinued. Two additional patients (0.1%, 2/1889) had events of hyperglycemia requiring insulin therapy that did not resolve at the time of reporting.

    IMFINZI with Tremelimumab-actl

    Two patients (0.5%, 2/388) had events of hyperglycemia requiring insulin therapy that had not resolved at last follow-up.

    IMFINZI with Tremelimumab-actl and Platinum-Based Chemotherapy

    Immune-mediated Type 1 diabetes mellitus occurred in 0.5% (3/596) of patients receiving IMFINZI in combination with tremelimumab-actl, including Grade 3 (0.3%) adverse reactions. All patients required endocrine therapy.

    Immune-Mediated Nephritis with Renal Dysfunction

    IMFINZI can cause immune-mediated nephritis.

    IMFINZI as a Single Agent

    Immune-mediated nephritis occurred in 0.5% (10/1889) of patients receiving IMFINZI, including Grade 3 (< 0.1%) adverse reactions. Events resolved in 5 of the 10 patients and resulted in permanent discontinuation in 3 patients. Systemic corticosteroids were required in all patients with immune-mediated nephritis.

    IMFINZI with Tremelimumab-actl

    Immune-mediated nephritis occurred in 1% (4/388) of patients receiving IMFINZI in combination with tremelimumab-actl, including Grade 3 (0.5%) adverse reactions. Events resolved in 3 of the 4 patients and resulted in permanent discontinuation in 2 patients. Systemic corticosteroids were required in all patients with immune-mediated nephritis; of these, 3 patients required high-dose corticosteroid treatment (at least 40 mg prednisone or equivalent per day).

    IMFINZI with Tremelimumab-actl and Platinum-Based Chemotherapy

    Immune-mediated nephritis occurred in 0.7% (4/596) of patients receiving IMFINZI in combination with tremelimumab-actl, including Grade 3 (0.2%) adverse reactions. Events resolved in 1 of the 4 patients and resulted in permanent discontinuation in 3 patients. Systemic corticosteroids were required in all patients with immune-mediated nephritis.

    Immune-Mediated Dermatology Reactions

    IMFINZI can cause immune-mediated rash or dermatitis. Exfoliative dermatitis, including Stevens Johnson Syndrome (SJS), drug rash with eosinophilia and systemic symptoms (DRESS), and toxic epidermal necrolysis (TEN), has occurred with PD-1/L-1 blocking antibodies. Topical emollients and/or topical corticosteroids may be adequate to treat mild to moderate non-exfoliative rashes. Withhold or permanently discontinue IMFINZI depending on severity

    [see
    Dosage and Administration (2.3)
    ]
    .

    IMFINZI as a Single Agent

    Immune-mediated rash or dermatitis occurred in 1.8% (34/1889) of patients receiving IMFINZI, including Grade 3 (0.4%) adverse reactions. Events resolved in 19 of the 34 patients and resulted in permanent discontinuation in 2 patients. Systemic corticosteroids were required in all patients with immune-mediated rash or dermatitis.

    IMFINZI with Tremelimumab-actl

    Immune-mediated rash or dermatitis occurred in 4.9% (19/388) of patients receiving IMFINZI in combination with tremelimumab-actl, including Grade 4 (0.3%) and Grade 3 (1.5%) adverse reactions. Events resolved in 13 of the 19 patients and resulted in permanent discontinuation in 2 patients. Systemic corticosteroids were required in all patients with immune-mediated rash or dermatitis; of these, 12 patients required high-dose corticosteroid treatment (at least 40 mg prednisone or equivalent per day). One patient received other immunosuppressants.

    IMFINZI with Tremelimumab-actl and Platinum-Based Chemotherapy

    Immune-mediated rash or dermatitis occurred in 7.2% (43/596) of patients receiving IMFINZI in combination with tremelimumab-actl, including Grade 3 (0.3%) adverse reactions. Events resolved in 32 of the 43 patients and resulted in permanent discontinuation in 2 patients. Systemic corticosteroids were required in all patients with immune-mediated rash or dermatitis.

    Immune-Mediated Pancreatitis

    IMFINZI in combination with tremelimumab-actl can cause immune-mediated pancreatitis.

    IMFINZI with Tremelimumab-actl

    Immune-mediated pancreatitis occurred in 2.3% (9/388) of patients receiving IMFINZI in combination with tremelimumab-actl, including Grade 4 (0.3%) and Grade 3 (1.5%) adverse reactions. Events resolved in 6 of the 9 patients. Systemic corticosteroids were required in all 9 patients, and of these 7 patients required high-dose corticosteroid treatment (at least 40 mg prednisone or equivalent per day).

    Other Immune-Mediated Adverse Reactions

    The following clinically significant, immune-mediated adverse reactions occurred at an incidence of less than 1% each in patients who received IMFINZI or IMFINZI in combination with tremelimumab-actl, or were reported with the use of other PD-1/PD-L1 blocking antibodies.

    Cardiac/vascular:
    Myocarditis, pericarditis, vasculitis.

    Nervous system:
    Meningitis, encephalitis, myelitis and demyelination, myasthenic syndrome/myasthenia gravis (including exacerbation), Guillain-Barré syndrome, nerve paresis, autoimmune neuropathy.

    Ocular:
    Uveitis, iritis, and other ocular inflammatory toxicities can occur. Some cases can be associated with retinal detachment. Various grades of visual impairment to include blindness can occur. If uveitis occurs in combination with other immune-mediated adverse reactions, consider a Vogt-Koyanagi-Harada-like syndrome, as this may require treatment with systemic steroids to reduce the risk of permanent vision loss.

    Gastrointestinal:
    Pancreatitis including increases in serum amylase and lipase levels, gastritis, duodenitis.

    Musculoskeletal and connective tissue disorders:
    Myositis/polymyositis, rhabdomyolysis and associated sequelae including renal failure, arthritis, polymyalgia rheumatic.

    Endocrine:
    Hypoparathyroidism.

    Other (hematologic/immune):
    Hemolytic anemia, aplastic anemia, hemophagocytic lymphohistiocytosis, systemic inflammatory response syndrome, histiocytic necrotizing lymphadenitis (Kikuchi lymphadenitis), sarcoidosis, immune thrombocytopenia, solid organ transplant rejection, other transplant (including corneal graft) rejection.

    )                                                              12/2024

    •  IMFINZI is a programmed death-ligand 1 (PD-L1) blocking antibody indicated:
    • •in combination with platinum-containing chemotherapy as neoadjuvant treatment, followed by IMFINZI continued as a single agent as adjuvant treatment after surgery, for the treatment of adult patients with resectable (tumors ≥ 4 cm and/or node positive) non-small cell lung cancer (NSCLC) and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements. (
      1.1 Non-Small Cell Lung Cancer
      • •
        IMFINZI in combination with platinum-containing chemotherapy as neoadjuvant treatment, followed by IMFINZI continued as a single agent as adjuvant treatment after surgery, is indicated for the treatment of adult patients with resectable (tumors ≥ 4 cm and/or node positive) non-small cell lung cancer (NSCLC) and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements.
      • •IMFINZI, as a single agent, is indicated for the treatment of adult patients with unresectable Stage III NSCLC whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy (cCRT).
      • •IMFINZI, in combination with tremelimumab-actl and platinum-based chemotherapy, is indicated for the treatment of adult patients with metastatic NSCLC with no sensitizing EGFR mutations or ALK genomic tumor aberrations.
      )
    • •as a single agent, for the treatment of adult patients with unresectable, Stage III NSCLC whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy. (
      1.1 Non-Small Cell Lung Cancer
      • •
        IMFINZI in combination with platinum-containing chemotherapy as neoadjuvant treatment, followed by IMFINZI continued as a single agent as adjuvant treatment after surgery, is indicated for the treatment of adult patients with resectable (tumors ≥ 4 cm and/or node positive) non-small cell lung cancer (NSCLC) and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements.
      • •IMFINZI, as a single agent, is indicated for the treatment of adult patients with unresectable Stage III NSCLC whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy (cCRT).
      • •IMFINZI, in combination with tremelimumab-actl and platinum-based chemotherapy, is indicated for the treatment of adult patients with metastatic NSCLC with no sensitizing EGFR mutations or ALK genomic tumor aberrations.
      )
    • •in combination with tremelimumab-actl and platinum-based chemotherapy, for the treatment of adult patients with metastatic NSCLC with no sensitizing EGFR mutations or ALK genomic tumor aberrations. (
      1.1 Non-Small Cell Lung Cancer
      • •
        IMFINZI in combination with platinum-containing chemotherapy as neoadjuvant treatment, followed by IMFINZI continued as a single agent as adjuvant treatment after surgery, is indicated for the treatment of adult patients with resectable (tumors ≥ 4 cm and/or node positive) non-small cell lung cancer (NSCLC) and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements.
      • •IMFINZI, as a single agent, is indicated for the treatment of adult patients with unresectable Stage III NSCLC whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy (cCRT).
      • •IMFINZI, in combination with tremelimumab-actl and platinum-based chemotherapy, is indicated for the treatment of adult patients with metastatic NSCLC with no sensitizing EGFR mutations or ALK genomic tumor aberrations.
      )
    • •as a single agent, for the treatment of adult patients with limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy. (
      1.2 Small Cell Lung Cancer
      • •
        IMFINZI, as a single agent, is indicated for the treatment of adult patients with limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy (cCRT).
      • •IMFINZI, in combination with etoposide and either carboplatin or cisplatin, is indicated for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC).
      )
    • •in combination with etoposide and either carboplatin or cisplatin, as first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC). (
      1.2 Small Cell Lung Cancer
      • •
        IMFINZI, as a single agent, is indicated for the treatment of adult patients with limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy (cCRT).
      • •IMFINZI, in combination with etoposide and either carboplatin or cisplatin, is indicated for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC).
      )
    • •in combination with gemcitabine and cisplatin, as treatment of adult patients with locally advanced or metastatic biliary tract cancer (BTC). (
      1.3 Biliary Tract Cancers

      IMFINZI, in combination with gemcitabine and cisplatin, is indicated for the treatment of adult patients with locally advanced or metastatic biliary tract cancer (BTC).

      )
    • •in combination with tremelimumab-actl, for the treatment of adult patients with unresectable hepatocellular carcinoma (uHCC). (
      1.4 Hepatocellular Carcinoma

      IMFINZI, in combination with tremelimumab-actl, is indicated for the treatment of adult patients with unresectable hepatocellular carcinoma (uHCC).

      )
    • •in combination with carboplatin and paclitaxel followed by IMFINZI as a single agent, for the treatment of adult patients with primary advanced or recurrent endometrial cancer that is mismatch repair deficient (dMMR) as determined by an FDA-approved test. (
      1.5 Endometrial Cancer

      IMFINZI, in combination with carboplatin and paclitaxel followed by IMFINZI as a single agent, is indicated for the treatment of adult patients with primary advanced or recurrent endometrial cancer that is mismatch repair deficient (dMMR) as determined by an FDA-approved test [see Dosage and Administration (2.1)].

      ,
      2.1 Patient Selection

      Advanced or Recurrent dMMR Endometrial Cancer

      Select patients for treatment based on the presence of dMMR in tumor specimens
      [see Clinical Studies (14.5)].

      Information on FDA-approved tests for the detection of dMMR status in endometrial cancer is available at
      https://www.fda.gov/companiondiagnostics
      .

      )
    • •in combination with gemcitabine and cisplatin as neoadjuvant treatment, followed by single agent IMFINZI as adjuvant treatment following radical cystectomy, for the treatment of adult patients with muscle invasive bladder cancer (MIBC). (
      1.6 Bladder Cancer

      IMFINZI in combination with gemcitabine and cisplatin as neoadjuvant treatment, followed by single agent IMFINZI as adjuvant treatment following radical cystectomy, is indicated for the treatment of adult patients with muscle invasive bladder cancer (MIBC).

      )
    • •in combination with fluorouracil, leucovorin, oxaliplatin, and docetaxel (FLOT) chemotherapy as neoadjuvant and adjuvant treatment, followed by single agent IMFINZI, for the treatment of adult patients with resectable gastric or gastroesophageal junction adenocarcinoma (GC/GEJC).
    • •Administer IMFINZI as an intravenous infusion over 60 minutes after dilution. (
      2.4 Preparation and Administration

      Preparation

      • •Visually inspect drug product for particulate matter and discoloration prior to administration, whenever solution and container permit. Discard the vial if the solution is cloudy, discolored, or visible particles are observed.
      • •Do not shake the vial.
      • •Withdraw the required volume from the vial(s) of IMFINZI and transfer into an intravenous bag containing 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP. Mix diluted solution by gentle inversion. Do not shake the solution. The final concentration of the diluted solution should be between 1 mg/mL and 15 mg/mL.
      • •Discard partially used or empty vials of IMFINZI.

      Storage of Infusion Solution

      • •IMFINZI does not contain a preservative.
      • •Administer infusion solution immediately once prepared. If the infusion solution is not administered immediately and needs to be stored, the time from preparation until the completion of the infusion should not exceed:
        • ∘28 days in a refrigerator at 2°C to 8°C (36°F to 46°F)
        • ∘8 hours at room temperature up to 25°C (77°F)
      • •Do not freeze.
      • •Do not shake.

      Administration

      • •Administer infusion solution intravenously over 60 minutes through an intravenous line containing a sterile, low-protein binding 0.2 or 0.22 micron in-line filter.
      • •Use separate infusion bags and filters for each drug product.

      IMFINZI in Combination with Other Products

      • •Administer all intravenous drug products as separate infusions.
      • •Do not co-administer other intravenous drugs through the same infusion line.
      • •For platinum-based chemotherapy, refer to Prescribing Information for administration information.
      • •For pemetrexed therapy, refer to Prescribing Information for administration information.

      Combination Regimens: Order of Infusions

      IMFINZI in Combination with Tremelimumab-actl

      • •Infuse tremelimumab-actl first, followed by IMFINZI on the same day of dosing.

      IMFINZI in Combination with Tremelimumab-actl and Platinum-Based Chemotherapy

      • •Infuse tremelimumab-actl first, followed by IMFINZI and then platinum-based chemotherapy on the day of dosing.

      IMFINZI in Combination with Tremelimumab-actl and Pemetrexed Therapy

      • •Infuse tremelimumab-actl first, followed by IMFINZI and then pemetrexed therapy on the day of dosing.

      IMFINZI in Combination with Chemotherapy

      • •
        Infuse IMFINZI first and then chemotherapy on the same day of dosing.

      Combination Regimens: Infusion Instructions

      IMFINZI in Combination with Tremelimumab-actl

      • •Administer tremelimumab-actl over 60 minutes followed by a 60 minute observation period. Then administer IMFINZI as a separate intravenous infusion over 60 minutes.

      IMFINZI in Combination with Tremelimumab-actl and Platinum-Based Chemotherapy/ Pemetrexed Therapy

      Cycle 1

      • •Infuse tremelimumab-actl over 60 minutes. One to two hours after completion of tremelimumab-actl infusion, infuse IMFINZI over 60 minutes. One to two hours after completion of IMFINZI infusion, administer platinum-based chemotherapy.

      Subsequent Cycles

      • •If there are no infusion reactions during cycle 1, subsequent cycles of IMFINZI can be given immediately after tremelimumab-actl. The time between the end of the IMFINZI infusion and the start of chemotherapy can be reduced to 30 minutes.
      )
    • •Neoadjuvant and Adjuvant Treatment of Resectable NSCLC:
      • ∘Weight ≥ 30 kg:

    Neoadjuvant
    : IMFINZI 1,500 mg in combination with chemotherapy every 3 weeks for up to 4 cycles prior to surgery.

    Adjuvant
    : IMFINZI 1,500 mg as a single agent every 4 weeks for up to 12 cycles after surgery. (
    2.2 Recommended Dosage

    The recommended dosages for IMFINZI as a single agent and IMFINZI in combination with other therapeutic agents are presented in Table 1. The recommended dosage schedule and regimens for IMFINZI for the treatment of metastatic NSCLC are provided in Tables 2 and 3

    [see Indications and Usage (1.1)].

    Administer IMFINZI as a 60 minute intravenous infusion after dilution

    [ see Dosage and Administration (2.3)].

    Table 1. Recommended Dosages of IMFINZI
    Indication
    Recommended IMFINZI Dosage
    Duration of Therapy
    Neoadjuvant and Adjuvant Treatment of Resectable NSCLC
    Patients with a body weight of ≥ 30 kg:


    Neoadjuvant: IMFINZI 1,500 mg in combination with chemotherapy
    Administer IMFINZI prior to chemotherapy on the same day. Refer to the Prescribing Information for the agent administered in combination with IMFINZI for recommended dosage information, as appropriate.
    every 3 weeks for up to 4 cycles prior to surgery


    Adjuvant: IMFINZI 1,500 mg as a single agent every 4 weeks for up to 12 cycles after surgery.


    Patients with a body weight of < 30 kg:

    Neoadjuvant: IMFINZI 20 mg/kg every 3 weeks in combination with chemotherapy
    for up to 4 cycles prior to surgery.

    Adjuvant: IMFINZI 20 mg/kg every 4 weeks for up to 12 cycles as a single agent after surgery.
    Until disease progression that precludes definitive surgery, recurrence, unacceptable toxicity, or a maximum of 12 cycles after surgery
    Unresectable Stage III NSCLCFollowing concurrent platinum-based chemotherapy and radiation therapy:

    Patients with a body weight of ≥ 30 kg:

    10 mg/kg every 2 weeks

    or

    1,500 mg every 4 weeks

    Patients with a body weight of < 30 kg:

    10 mg/kg every 2 weeks    		Until disease progression, unacceptable toxicity, or a maximum of 12 months
    Limited Stage SCLCFollowing concurrent platinum-based chemotherapy and radiation therapy:

    Patients with a body weight of ≥ 30 kg:

    1,500 mg every 4 weeks


    Patients with a body weight of < 30 kg:

    20 mg/kg every 4 weeks
    		Until disease progression, unacceptable toxicity, or a maximum of 24 months
    Extensive Stage SCLCPatients with a body weight of ≥ 30 kg:

    1,500 mg in combination with chemotherapy
    every 3 weeks (21 days) for 4 cycles, followed by 1,500 mg every 4 weeks as a single agent

    Patients with a body weight of < 30 kg:

    20 mg/kg in combination with chemotherapy
    every 3 weeks (21 days) for 4 cycles, followed by 10 mg/kg every 2 weeks as a single agent    		Until disease progression or until unacceptable toxicity
    BTCPatients with a body weight of ≥ 30 kg:

    1,500 mg in combination with chemotherapy
    every 3 weeks (21 days) up to 8 cycles followed by 1,500 mg every 4 weeks as a single agent

    Patients with a body weight of < 30 kg:

    20 mg/kg in combination with chemotherapy
    every 3 weeks (21 days) up to 8 cycles, followed by 20 mg/kg every 4 weeks as a single agent    		Until disease progression or until unacceptable toxicity
    uHCCPatients with a body weight of ≥ 30 kg:

    IMFINZI 1,500 mg following a single dose of tremelimumab-actlAdminister tremelimumab-actl prior to IMFINZI on the same day. When tremelimumab-actl is administered in combination with IMFINZI, refer to the Prescribing Information for tremelimumab-actl dosing information.300 mg at Day 1 of Cycle 1;

    Continue IMFINZI 1,500 mg as a single agent every 4 weeks

    Patients with a body weight of < 30 kg:

    IMFINZI 20 mg/kg following a single dose of tremelimumab-actl
    4 mg/kg at Day 1 of Cycle 1;

    Continue IMFINZI 20 mg/kg as a single agent every 4 weeks    		After Cycle 1 of combination therapy, administer IMFINZI as a single agent every 4 weeks until disease progression or unacceptable toxicity
    dMMR endometrial cancer
    Patients with a body weight of ≥ 30 kg:


    IMFINZI 1,120 mg in combination with carboplatin and paclitaxel
    every 3 weeks (21 days) for 6 cycles, followed by IMFINZI 1,500 mg every 4 weeks as a single agent


    Patients with a body weight of < 30 kg:


    IMFINZI 15 mg/kg in combination with carboplatin and paclitaxel
    every 3 weeks (21 days) for 6 cycles, followed by IMFINZI 20 mg/kg every 4 weeks as a single agent
    Until disease progression or unacceptable toxicity
    Neoadjuvant and Adjuvant Treatment of MIBC
    Patients with a body weight of ≥30 kg:


    Neoadjuvant: 1,500 mg in combination with gemcitabine and cisplatin
    every 3 weeks for 4 cycles prior to surgery


    Adjuvant: IMFINZI 1,500 mg as a single agent every 4 weeks for up to 8 cycles after surgery


    Patients with a body weight of < 30 kg:


    Neoadjuvant: 20 mg/kg in combination with gemcitabine and cisplatin
    every 3 weeks for 4 cycles prior to surgery


    Adjuvant: IMFINZI 20 mg/kg as a single agent every 4 weeks for up to 8 cycles after surgery
    Until disease progression that precludes definitive surgery, recurrence, or unacceptable toxicity or a maximum of 8 cycles after surgery
    Neoadjuvant and Adjuvant


    Treatment of Resectable


    GC/GEJC
    Patients with a body weight of ≥ 30


    kg:


    Neoadjuvant: IMFINZI 1,500 mg every 4 weeks with FLOT
    FLOT chemotherapy is administered on days 1 and 15 of each 4 week cycle
    [See Clinical Studies ]
    .
    for up to 2 cycles prior to surgery


    Adjuvant: IMFINZI 1,500 mg every 4 weeks with FLOT
    for up to 2 cycles, followed by IMFINZI 1,500 mg as a single agent every 4 weeks for up to 10 cycles


    Patients with a body weight of < 30 kg:


    Neoadjuvant: IMFINZI 20 mg/kg every 4 weeks with FLOT*± for up to 2 cycles prior to surgery


    Adjuvant: IMFINZI 20 mg/kg every 4 weeks with FLOT
    for up to 2 cycles, followed by IMFINZI 20 mg/kg as a single agent every 4 weeks for up to 10 cycles
    Neoadjuvant: Until disease progression that precludes definitive surgery or unacceptable toxicity

    IMFINZI in Combination with Tremelimumab-actl and Platinum-Based Chemotherapy

    The recommended dosage schedule and regimens for IMFINZI for the treatment of metastatic NSCLC are provided in Tables 2 and 3.

    Weigh patients prior to each infusion.

    Calculate the appropriate dose using Table 3 below based on the patient’s weight and tumor histology.

    Table 2. Recommended Dosage Schedule for Metastatic NSCLC
    Week
    continue IMFINZI until disease progression or intolerable toxicity.note the dosing interval change from every 3 weeks to every 4 weeks starting at cycle 5.
    0123456789101112131415161718192021222324
    Cycle:
    		12345678

    IMFINZI

    intravenous infusion over 60 minutes
    [see
    Dosage and Administration (2.4)
    ]
    .

    X

    X

    X

    X

    X

    X

    X

    X

    Tremelimumab-actl

    if patients receive fewer than 4 cycles of platinum-based chemotherapy, the remaining cycles of tremelimumab-actl (up to a total of 5) should be given after the platinum-based chemotherapy phase, in combination with IMFINZI, every 4 weeks.

    X

    X

    X

    X

    X

    Chemotherapy

    X

    X

    X

    X

    Xoptional pemetrexed therapy from week 12 until disease progression or intolerable toxicity for patients with non-squamous disease who received treatment with pemetrexed and carboplatin/cisplatin.

    X

    X

    X

    carboplatin & nab-paclitaxel

    OR

    carboplatin or cisplatin & pemetrexedcarboplatin & nab-paclitaxel

    OR

    carboplatin or cisplatin & gemcitabine
    Table 3. Recommended Regimen and Dosage for Metastatic NSCLC
    Tumor Histology
    Patient Weight
    IMFINZI Dosage
    Tremelimumab-actl DosageRefer to the Prescribing Information for dosing information.
    Platinum-based Chemotherapy Regimen

    Non-Squamous

    ≥ 30 kg

    1,500 mg

    75 mg

    ••

    < 30 kg

    20 mg/kg

    1 mg/kg

    Squamous

    ≥ 30 kg

    1,500 mg

    75 mg

    ••

    < 30 kg

    20 mg/kg

    1 mg/kg

    )

    •  
      • ∘Weight < 30 kg

    Neoadjuvant
    : IMFINZI 20 mg/kg every 3 weeks in combination with chemotherapy for up to 4 cycles prior to surgery.

    Adjuvant
    : 20 mg/kg every 4 weeks as a single agent for up to 12 cycles after surgery. (
    2.2 Recommended Dosage

    The recommended dosages for IMFINZI as a single agent and IMFINZI in combination with other therapeutic agents are presented in Table 1. The recommended dosage schedule and regimens for IMFINZI for the treatment of metastatic NSCLC are provided in Tables 2 and 3

    [see Indications and Usage (1.1)].

    Administer IMFINZI as a 60 minute intravenous infusion after dilution

    [ see Dosage and Administration (2.3)].

    Table 1. Recommended Dosages of IMFINZI
    Indication
    Recommended IMFINZI Dosage
    Duration of Therapy
    Neoadjuvant and Adjuvant Treatment of Resectable NSCLC
    Patients with a body weight of ≥ 30 kg:


    Neoadjuvant: IMFINZI 1,500 mg in combination with chemotherapy
    Administer IMFINZI prior to chemotherapy on the same day. Refer to the Prescribing Information for the agent administered in combination with IMFINZI for recommended dosage information, as appropriate.
    every 3 weeks for up to 4 cycles prior to surgery


    Adjuvant: IMFINZI 1,500 mg as a single agent every 4 weeks for up to 12 cycles after surgery.


    Patients with a body weight of < 30 kg:

    Neoadjuvant: IMFINZI 20 mg/kg every 3 weeks in combination with chemotherapy
    for up to 4 cycles prior to surgery.

    Adjuvant: IMFINZI 20 mg/kg every 4 weeks for up to 12 cycles as a single agent after surgery.
    Until disease progression that precludes definitive surgery, recurrence, unacceptable toxicity, or a maximum of 12 cycles after surgery
    Unresectable Stage III NSCLCFollowing concurrent platinum-based chemotherapy and radiation therapy:

    Patients with a body weight of ≥ 30 kg:

    10 mg/kg every 2 weeks

    or

    1,500 mg every 4 weeks

    Patients with a body weight of < 30 kg:

    10 mg/kg every 2 weeks    		Until disease progression, unacceptable toxicity, or a maximum of 12 months
    Limited Stage SCLCFollowing concurrent platinum-based chemotherapy and radiation therapy:

    Patients with a body weight of ≥ 30 kg:

    1,500 mg every 4 weeks


    Patients with a body weight of < 30 kg:

    20 mg/kg every 4 weeks
    		Until disease progression, unacceptable toxicity, or a maximum of 24 months
    Extensive Stage SCLCPatients with a body weight of ≥ 30 kg:

    1,500 mg in combination with chemotherapy
    every 3 weeks (21 days) for 4 cycles, followed by 1,500 mg every 4 weeks as a single agent

    Patients with a body weight of < 30 kg:

    20 mg/kg in combination with chemotherapy
    every 3 weeks (21 days) for 4 cycles, followed by 10 mg/kg every 2 weeks as a single agent    		Until disease progression or until unacceptable toxicity
    BTCPatients with a body weight of ≥ 30 kg:

    1,500 mg in combination with chemotherapy
    every 3 weeks (21 days) up to 8 cycles followed by 1,500 mg every 4 weeks as a single agent

    Patients with a body weight of < 30 kg:

    20 mg/kg in combination with chemotherapy
    every 3 weeks (21 days) up to 8 cycles, followed by 20 mg/kg every 4 weeks as a single agent    		Until disease progression or until unacceptable toxicity
    uHCCPatients with a body weight of ≥ 30 kg:

    IMFINZI 1,500 mg following a single dose of tremelimumab-actlAdminister tremelimumab-actl prior to IMFINZI on the same day. When tremelimumab-actl is administered in combination with IMFINZI, refer to the Prescribing Information for tremelimumab-actl dosing information.300 mg at Day 1 of Cycle 1;

    Continue IMFINZI 1,500 mg as a single agent every 4 weeks

    Patients with a body weight of < 30 kg:

    IMFINZI 20 mg/kg following a single dose of tremelimumab-actl
    4 mg/kg at Day 1 of Cycle 1;

    Continue IMFINZI 20 mg/kg as a single agent every 4 weeks    		After Cycle 1 of combination therapy, administer IMFINZI as a single agent every 4 weeks until disease progression or unacceptable toxicity
    dMMR endometrial cancer
    Patients with a body weight of ≥ 30 kg:


    IMFINZI 1,120 mg in combination with carboplatin and paclitaxel
    every 3 weeks (21 days) for 6 cycles, followed by IMFINZI 1,500 mg every 4 weeks as a single agent


    Patients with a body weight of < 30 kg:


    IMFINZI 15 mg/kg in combination with carboplatin and paclitaxel
    every 3 weeks (21 days) for 6 cycles, followed by IMFINZI 20 mg/kg every 4 weeks as a single agent
    Until disease progression or unacceptable toxicity
    Neoadjuvant and Adjuvant Treatment of MIBC
    Patients with a body weight of ≥30 kg:


    Neoadjuvant: 1,500 mg in combination with gemcitabine and cisplatin
    every 3 weeks for 4 cycles prior to surgery


    Adjuvant: IMFINZI 1,500 mg as a single agent every 4 weeks for up to 8 cycles after surgery


    Patients with a body weight of < 30 kg:


    Neoadjuvant: 20 mg/kg in combination with gemcitabine and cisplatin
    every 3 weeks for 4 cycles prior to surgery


    Adjuvant: IMFINZI 20 mg/kg as a single agent every 4 weeks for up to 8 cycles after surgery
    Until disease progression that precludes definitive surgery, recurrence, or unacceptable toxicity or a maximum of 8 cycles after surgery
    Neoadjuvant and Adjuvant


    Treatment of Resectable


    GC/GEJC
    Patients with a body weight of ≥ 30


    kg:


    Neoadjuvant: IMFINZI 1,500 mg every 4 weeks with FLOT
    FLOT chemotherapy is administered on days 1 and 15 of each 4 week cycle
    [See Clinical Studies ]
    .
    for up to 2 cycles prior to surgery


    Adjuvant: IMFINZI 1,500 mg every 4 weeks with FLOT
    for up to 2 cycles, followed by IMFINZI 1,500 mg as a single agent every 4 weeks for up to 10 cycles


    Patients with a body weight of < 30 kg:


    Neoadjuvant: IMFINZI 20 mg/kg every 4 weeks with FLOT*± for up to 2 cycles prior to surgery


    Adjuvant: IMFINZI 20 mg/kg every 4 weeks with FLOT
    for up to 2 cycles, followed by IMFINZI 20 mg/kg as a single agent every 4 weeks for up to 10 cycles
    Neoadjuvant: Until disease progression that precludes definitive surgery or unacceptable toxicity

    IMFINZI in Combination with Tremelimumab-actl and Platinum-Based Chemotherapy

    The recommended dosage schedule and regimens for IMFINZI for the treatment of metastatic NSCLC are provided in Tables 2 and 3.

    Weigh patients prior to each infusion.

    Calculate the appropriate dose using Table 3 below based on the patient’s weight and tumor histology.

    Table 2. Recommended Dosage Schedule for Metastatic NSCLC
    Week
    continue IMFINZI until disease progression or intolerable toxicity.note the dosing interval change from every 3 weeks to every 4 weeks starting at cycle 5.
    0123456789101112131415161718192021222324
    Cycle:
    		12345678

    IMFINZI

    intravenous infusion over 60 minutes
    [see
    Dosage and Administration (2.4)
    ]
    .

    X

    X

    X

    X

    X

    X

    X

    X

    Tremelimumab-actl

    if patients receive fewer than 4 cycles of platinum-based chemotherapy, the remaining cycles of tremelimumab-actl (up to a total of 5) should be given after the platinum-based chemotherapy phase, in combination with IMFINZI, every 4 weeks.

    X

    X

    X

    X

    X

    Chemotherapy

    X

    X

    X

    X

    Xoptional pemetrexed therapy from week 12 until disease progression or intolerable toxicity for patients with non-squamous disease who received treatment with pemetrexed and carboplatin/cisplatin.

    X

    X

    X

    carboplatin & nab-paclitaxel

    OR

    carboplatin or cisplatin & pemetrexedcarboplatin & nab-paclitaxel

    OR

    carboplatin or cisplatin & gemcitabine
    Table 3. Recommended Regimen and Dosage for Metastatic NSCLC
    Tumor Histology
    Patient Weight
    IMFINZI Dosage
    Tremelimumab-actl DosageRefer to the Prescribing Information for dosing information.
    Platinum-based Chemotherapy Regimen

    Non-Squamous

    ≥ 30 kg

    1,500 mg

    75 mg

    ••

    < 30 kg

    20 mg/kg

    1 mg/kg

    Squamous

    ≥ 30 kg

    1,500 mg

    75 mg

    ••

    < 30 kg

    20 mg/kg

    1 mg/kg

    )

    • •Unresectable Stage III NSCLC, following concurrent platinum-based chemotherapy and radiation therapy:
      • ∘Weight ≥ 30 kg: IMFINZI 10 mg/kg every 2 weeks or 1,500 mg every 4 weeks. (
        2.2 Recommended Dosage

        The recommended dosages for IMFINZI as a single agent and IMFINZI in combination with other therapeutic agents are presented in Table 1. The recommended dosage schedule and regimens for IMFINZI for the treatment of metastatic NSCLC are provided in Tables 2 and 3

        [see Indications and Usage (1.1)].

        Administer IMFINZI as a 60 minute intravenous infusion after dilution

        [ see Dosage and Administration (2.3)].

        Table 1. Recommended Dosages of IMFINZI
        Indication
        Recommended IMFINZI Dosage
        Duration of Therapy
        Neoadjuvant and Adjuvant Treatment of Resectable NSCLC
        Patients with a body weight of ≥ 30 kg:


        Neoadjuvant: IMFINZI 1,500 mg in combination with chemotherapy
        Administer IMFINZI prior to chemotherapy on the same day. Refer to the Prescribing Information for the agent administered in combination with IMFINZI for recommended dosage information, as appropriate.
        every 3 weeks for up to 4 cycles prior to surgery


        Adjuvant: IMFINZI 1,500 mg as a single agent every 4 weeks for up to 12 cycles after surgery.


        Patients with a body weight of < 30 kg:

        Neoadjuvant: IMFINZI 20 mg/kg every 3 weeks in combination with chemotherapy
        for up to 4 cycles prior to surgery.

        Adjuvant: IMFINZI 20 mg/kg every 4 weeks for up to 12 cycles as a single agent after surgery.
        Until disease progression that precludes definitive surgery, recurrence, unacceptable toxicity, or a maximum of 12 cycles after surgery
        Unresectable Stage III NSCLCFollowing concurrent platinum-based chemotherapy and radiation therapy:

        Patients with a body weight of ≥ 30 kg:

        10 mg/kg every 2 weeks

        or

        1,500 mg every 4 weeks

        Patients with a body weight of < 30 kg:

        10 mg/kg every 2 weeks        		Until disease progression, unacceptable toxicity, or a maximum of 12 months
        Limited Stage SCLCFollowing concurrent platinum-based chemotherapy and radiation therapy:

        Patients with a body weight of ≥ 30 kg:

        1,500 mg every 4 weeks


        Patients with a body weight of < 30 kg:

        20 mg/kg every 4 weeks
        		Until disease progression, unacceptable toxicity, or a maximum of 24 months
        Extensive Stage SCLCPatients with a body weight of ≥ 30 kg:

        1,500 mg in combination with chemotherapy
        every 3 weeks (21 days) for 4 cycles, followed by 1,500 mg every 4 weeks as a single agent

        Patients with a body weight of < 30 kg:

        20 mg/kg in combination with chemotherapy
        every 3 weeks (21 days) for 4 cycles, followed by 10 mg/kg every 2 weeks as a single agent        		Until disease progression or until unacceptable toxicity
        BTCPatients with a body weight of ≥ 30 kg:

        1,500 mg in combination with chemotherapy
        every 3 weeks (21 days) up to 8 cycles followed by 1,500 mg every 4 weeks as a single agent

        Patients with a body weight of < 30 kg:

        20 mg/kg in combination with chemotherapy
        every 3 weeks (21 days) up to 8 cycles, followed by 20 mg/kg every 4 weeks as a single agent        		Until disease progression or until unacceptable toxicity
        uHCCPatients with a body weight of ≥ 30 kg:

        IMFINZI 1,500 mg following a single dose of tremelimumab-actlAdminister tremelimumab-actl prior to IMFINZI on the same day. When tremelimumab-actl is administered in combination with IMFINZI, refer to the Prescribing Information for tremelimumab-actl dosing information.300 mg at Day 1 of Cycle 1;

        Continue IMFINZI 1,500 mg as a single agent every 4 weeks

        Patients with a body weight of < 30 kg:

        IMFINZI 20 mg/kg following a single dose of tremelimumab-actl
        4 mg/kg at Day 1 of Cycle 1;

        Continue IMFINZI 20 mg/kg as a single agent every 4 weeks        		After Cycle 1 of combination therapy, administer IMFINZI as a single agent every 4 weeks until disease progression or unacceptable toxicity
        dMMR endometrial cancer
        Patients with a body weight of ≥ 30 kg:


        IMFINZI 1,120 mg in combination with carboplatin and paclitaxel
        every 3 weeks (21 days) for 6 cycles, followed by IMFINZI 1,500 mg every 4 weeks as a single agent


        Patients with a body weight of < 30 kg:


        IMFINZI 15 mg/kg in combination with carboplatin and paclitaxel
        every 3 weeks (21 days) for 6 cycles, followed by IMFINZI 20 mg/kg every 4 weeks as a single agent
        Until disease progression or unacceptable toxicity
        Neoadjuvant and Adjuvant Treatment of MIBC
        Patients with a body weight of ≥30 kg:


        Neoadjuvant: 1,500 mg in combination with gemcitabine and cisplatin
        every 3 weeks for 4 cycles prior to surgery


        Adjuvant: IMFINZI 1,500 mg as a single agent every 4 weeks for up to 8 cycles after surgery


        Patients with a body weight of < 30 kg:


        Neoadjuvant: 20 mg/kg in combination with gemcitabine and cisplatin
        every 3 weeks for 4 cycles prior to surgery


        Adjuvant: IMFINZI 20 mg/kg as a single agent every 4 weeks for up to 8 cycles after surgery
        Until disease progression that precludes definitive surgery, recurrence, or unacceptable toxicity or a maximum of 8 cycles after surgery
        Neoadjuvant and Adjuvant


        Treatment of Resectable


        GC/GEJC
        Patients with a body weight of ≥ 30


        kg:


        Neoadjuvant: IMFINZI 1,500 mg every 4 weeks with FLOT
        FLOT chemotherapy is administered on days 1 and 15 of each 4 week cycle
        [See Clinical Studies ]
        .
        for up to 2 cycles prior to surgery


        Adjuvant: IMFINZI 1,500 mg every 4 weeks with FLOT
        for up to 2 cycles, followed by IMFINZI 1,500 mg as a single agent every 4 weeks for up to 10 cycles


        Patients with a body weight of < 30 kg:


        Neoadjuvant: IMFINZI 20 mg/kg every 4 weeks with FLOT*± for up to 2 cycles prior to surgery


        Adjuvant: IMFINZI 20 mg/kg every 4 weeks with FLOT
        for up to 2 cycles, followed by IMFINZI 20 mg/kg as a single agent every 4 weeks for up to 10 cycles
        Neoadjuvant: Until disease progression that precludes definitive surgery or unacceptable toxicity

        IMFINZI in Combination with Tremelimumab-actl and Platinum-Based Chemotherapy

        The recommended dosage schedule and regimens for IMFINZI for the treatment of metastatic NSCLC are provided in Tables 2 and 3.

        Weigh patients prior to each infusion.

        Calculate the appropriate dose using Table 3 below based on the patient’s weight and tumor histology.

        Table 2. Recommended Dosage Schedule for Metastatic NSCLC
        Week
        continue IMFINZI until disease progression or intolerable toxicity.note the dosing interval change from every 3 weeks to every 4 weeks starting at cycle 5.
        0123456789101112131415161718192021222324
        Cycle:
        		12345678

        IMFINZI

        intravenous infusion over 60 minutes
        [see
        Dosage and Administration (2.4)
        ]
        .

        X

        X

        X

        X

        X

        X

        X

        X

        Tremelimumab-actl

        if patients receive fewer than 4 cycles of platinum-based chemotherapy, the remaining cycles of tremelimumab-actl (up to a total of 5) should be given after the platinum-based chemotherapy phase, in combination with IMFINZI, every 4 weeks.

        X

        X

        X

        X

        X

        Chemotherapy

        X

        X

        X

        X

        Xoptional pemetrexed therapy from week 12 until disease progression or intolerable toxicity for patients with non-squamous disease who received treatment with pemetrexed and carboplatin/cisplatin.

        X

        X

        X

        carboplatin & nab-paclitaxel

        OR

        carboplatin or cisplatin & pemetrexedcarboplatin & nab-paclitaxel

        OR

        carboplatin or cisplatin & gemcitabine
        Table 3. Recommended Regimen and Dosage for Metastatic NSCLC
        Tumor Histology
        Patient Weight
        IMFINZI Dosage
        Tremelimumab-actl DosageRefer to the Prescribing Information for dosing information.
        Platinum-based Chemotherapy Regimen

        Non-Squamous

        ≥ 30 kg

        1,500 mg

        75 mg

        ••

        < 30 kg

        20 mg/kg

        1 mg/kg

        Squamous

        ≥ 30 kg

        1,500 mg

        75 mg

        ••

        < 30 kg

        20 mg/kg

        1 mg/kg

        )
      • ∘Weight < 30 kg: IMFINZI 10 mg/kg every 2 weeks. (
        2.2 Recommended Dosage

        The recommended dosages for IMFINZI as a single agent and IMFINZI in combination with other therapeutic agents are presented in Table 1. The recommended dosage schedule and regimens for IMFINZI for the treatment of metastatic NSCLC are provided in Tables 2 and 3

        [see Indications and Usage (1.1)].

        Administer IMFINZI as a 60 minute intravenous infusion after dilution

        [ see Dosage and Administration (2.3)].

        Table 1. Recommended Dosages of IMFINZI
        Indication
        Recommended IMFINZI Dosage
        Duration of Therapy
        Neoadjuvant and Adjuvant Treatment of Resectable NSCLC
        Patients with a body weight of ≥ 30 kg:


        Neoadjuvant: IMFINZI 1,500 mg in combination with chemotherapy
        Administer IMFINZI prior to chemotherapy on the same day. Refer to the Prescribing Information for the agent administered in combination with IMFINZI for recommended dosage information, as appropriate.
        every 3 weeks for up to 4 cycles prior to surgery


        Adjuvant: IMFINZI 1,500 mg as a single agent every 4 weeks for up to 12 cycles after surgery.


        Patients with a body weight of < 30 kg:

        Neoadjuvant: IMFINZI 20 mg/kg every 3 weeks in combination with chemotherapy
        for up to 4 cycles prior to surgery.

        Adjuvant: IMFINZI 20 mg/kg every 4 weeks for up to 12 cycles as a single agent after surgery.
        Until disease progression that precludes definitive surgery, recurrence, unacceptable toxicity, or a maximum of 12 cycles after surgery
        Unresectable Stage III NSCLCFollowing concurrent platinum-based chemotherapy and radiation therapy:

        Patients with a body weight of ≥ 30 kg:

        10 mg/kg every 2 weeks

        or

        1,500 mg every 4 weeks

        Patients with a body weight of < 30 kg:

        10 mg/kg every 2 weeks        		Until disease progression, unacceptable toxicity, or a maximum of 12 months
        Limited Stage SCLCFollowing concurrent platinum-based chemotherapy and radiation therapy:

        Patients with a body weight of ≥ 30 kg:

        1,500 mg every 4 weeks


        Patients with a body weight of < 30 kg:

        20 mg/kg every 4 weeks
        		Until disease progression, unacceptable toxicity, or a maximum of 24 months
        Extensive Stage SCLCPatients with a body weight of ≥ 30 kg:

        1,500 mg in combination with chemotherapy
        every 3 weeks (21 days) for 4 cycles, followed by 1,500 mg every 4 weeks as a single agent

        Patients with a body weight of < 30 kg:

        20 mg/kg in combination with chemotherapy
        every 3 weeks (21 days) for 4 cycles, followed by 10 mg/kg every 2 weeks as a single agent        		Until disease progression or until unacceptable toxicity
        BTCPatients with a body weight of ≥ 30 kg:

        1,500 mg in combination with chemotherapy
        every 3 weeks (21 days) up to 8 cycles followed by 1,500 mg every 4 weeks as a single agent

        Patients with a body weight of < 30 kg:

        20 mg/kg in combination with chemotherapy
        every 3 weeks (21 days) up to 8 cycles, followed by 20 mg/kg every 4 weeks as a single agent        		Until disease progression or until unacceptable toxicity
        uHCCPatients with a body weight of ≥ 30 kg:

        IMFINZI 1,500 mg following a single dose of tremelimumab-actlAdminister tremelimumab-actl prior to IMFINZI on the same day. When tremelimumab-actl is administered in combination with IMFINZI, refer to the Prescribing Information for tremelimumab-actl dosing information.300 mg at Day 1 of Cycle 1;

        Continue IMFINZI 1,500 mg as a single agent every 4 weeks

        Patients with a body weight of < 30 kg:

        IMFINZI 20 mg/kg following a single dose of tremelimumab-actl
        4 mg/kg at Day 1 of Cycle 1;

        Continue IMFINZI 20 mg/kg as a single agent every 4 weeks        		After Cycle 1 of combination therapy, administer IMFINZI as a single agent every 4 weeks until disease progression or unacceptable toxicity
        dMMR endometrial cancer
        Patients with a body weight of ≥ 30 kg:


        IMFINZI 1,120 mg in combination with carboplatin and paclitaxel
        every 3 weeks (21 days) for 6 cycles, followed by IMFINZI 1,500 mg every 4 weeks as a single agent


        Patients with a body weight of < 30 kg:


        IMFINZI 15 mg/kg in combination with carboplatin and paclitaxel
        every 3 weeks (21 days) for 6 cycles, followed by IMFINZI 20 mg/kg every 4 weeks as a single agent
        Until disease progression or unacceptable toxicity
        Neoadjuvant and Adjuvant Treatment of MIBC
        Patients with a body weight of ≥30 kg:


        Neoadjuvant: 1,500 mg in combination with gemcitabine and cisplatin
        every 3 weeks for 4 cycles prior to surgery


        Adjuvant: IMFINZI 1,500 mg as a single agent every 4 weeks for up to 8 cycles after surgery


        Patients with a body weight of < 30 kg:


        Neoadjuvant: 20 mg/kg in combination with gemcitabine and cisplatin
        every 3 weeks for 4 cycles prior to surgery


        Adjuvant: IMFINZI 20 mg/kg as a single agent every 4 weeks for up to 8 cycles after surgery
        Until disease progression that precludes definitive surgery, recurrence, or unacceptable toxicity or a maximum of 8 cycles after surgery
        Neoadjuvant and Adjuvant


        Treatment of Resectable


        GC/GEJC
        Patients with a body weight of ≥ 30


        kg:


        Neoadjuvant: IMFINZI 1,500 mg every 4 weeks with FLOT
        FLOT chemotherapy is administered on days 1 and 15 of each 4 week cycle
        [See Clinical Studies ]
        .
        for up to 2 cycles prior to surgery


        Adjuvant: IMFINZI 1,500 mg every 4 weeks with FLOT
        for up to 2 cycles, followed by IMFINZI 1,500 mg as a single agent every 4 weeks for up to 10 cycles


        Patients with a body weight of < 30 kg:


        Neoadjuvant: IMFINZI 20 mg/kg every 4 weeks with FLOT*± for up to 2 cycles prior to surgery


        Adjuvant: IMFINZI 20 mg/kg every 4 weeks with FLOT
        for up to 2 cycles, followed by IMFINZI 20 mg/kg as a single agent every 4 weeks for up to 10 cycles
        Neoadjuvant: Until disease progression that precludes definitive surgery or unacceptable toxicity

        IMFINZI in Combination with Tremelimumab-actl and Platinum-Based Chemotherapy

        The recommended dosage schedule and regimens for IMFINZI for the treatment of metastatic NSCLC are provided in Tables 2 and 3.

        Weigh patients prior to each infusion.

        Calculate the appropriate dose using Table 3 below based on the patient’s weight and tumor histology.

        Table 2. Recommended Dosage Schedule for Metastatic NSCLC
        Week
        continue IMFINZI until disease progression or intolerable toxicity.note the dosing interval change from every 3 weeks to every 4 weeks starting at cycle 5.
        0123456789101112131415161718192021222324
        Cycle:
        		12345678

        IMFINZI

        intravenous infusion over 60 minutes
        [see
        Dosage and Administration (2.4)
        ]
        .

        X

        X

        X

        X

        X

        X

        X

        X

        Tremelimumab-actl

        if patients receive fewer than 4 cycles of platinum-based chemotherapy, the remaining cycles of tremelimumab-actl (up to a total of 5) should be given after the platinum-based chemotherapy phase, in combination with IMFINZI, every 4 weeks.

        X

        X

        X

        X

        X

        Chemotherapy

        X

        X

        X

        X

        Xoptional pemetrexed therapy from week 12 until disease progression or intolerable toxicity for patients with non-squamous disease who received treatment with pemetrexed and carboplatin/cisplatin.

        X

        X

        X

        carboplatin & nab-paclitaxel

        OR

        carboplatin or cisplatin & pemetrexedcarboplatin & nab-paclitaxel

        OR

        carboplatin or cisplatin & gemcitabine
        Table 3. Recommended Regimen and Dosage for Metastatic NSCLC
        Tumor Histology
        Patient Weight
        IMFINZI Dosage
        Tremelimumab-actl DosageRefer to the Prescribing Information for dosing information.
        Platinum-based Chemotherapy Regimen

        Non-Squamous

        ≥ 30 kg

        1,500 mg

        75 mg

        ••

        < 30 kg

        20 mg/kg

        1 mg/kg

        Squamous

        ≥ 30 kg

        1,500 mg

        75 mg

        ••

        < 30 kg

        20 mg/kg

        1 mg/kg

        )
    • •Metastatic NSCLC:
      • ∘Weight ≥ 30 kg: IMFINZI 1,500 mg every 3 weeks in combination with tremelimumab-actl 75 mg and platinum-based chemotherapy for 4 cycles, and then administer IMFINZI 1,500 mg every 4 weeks as a single agent with histology-based pemetrexed maintenance therapy every 4 weeks, and a fifth dose of tremelimumab-actl 75 mg in combination with IMFINZI dose 6 at week 16. (
        2.2 Recommended Dosage

        The recommended dosages for IMFINZI as a single agent and IMFINZI in combination with other therapeutic agents are presented in Table 1. The recommended dosage schedule and regimens for IMFINZI for the treatment of metastatic NSCLC are provided in Tables 2 and 3

        [see Indications and Usage (1.1)].

        Administer IMFINZI as a 60 minute intravenous infusion after dilution

        [ see Dosage and Administration (2.3)].

        Table 1. Recommended Dosages of IMFINZI
        Indication
        Recommended IMFINZI Dosage
        Duration of Therapy
        Neoadjuvant and Adjuvant Treatment of Resectable NSCLC
        Patients with a body weight of ≥ 30 kg:


        Neoadjuvant: IMFINZI 1,500 mg in combination with chemotherapy
        Administer IMFINZI prior to chemotherapy on the same day. Refer to the Prescribing Information for the agent administered in combination with IMFINZI for recommended dosage information, as appropriate.
        every 3 weeks for up to 4 cycles prior to surgery


        Adjuvant: IMFINZI 1,500 mg as a single agent every 4 weeks for up to 12 cycles after surgery.


        Patients with a body weight of < 30 kg:

        Neoadjuvant: IMFINZI 20 mg/kg every 3 weeks in combination with chemotherapy
        for up to 4 cycles prior to surgery.

        Adjuvant: IMFINZI 20 mg/kg every 4 weeks for up to 12 cycles as a single agent after surgery.
        Until disease progression that precludes definitive surgery, recurrence, unacceptable toxicity, or a maximum of 12 cycles after surgery
        Unresectable Stage III NSCLCFollowing concurrent platinum-based chemotherapy and radiation therapy:

        Patients with a body weight of ≥ 30 kg:

        10 mg/kg every 2 weeks

        or

        1,500 mg every 4 weeks

        Patients with a body weight of < 30 kg:

        10 mg/kg every 2 weeks        		Until disease progression, unacceptable toxicity, or a maximum of 12 months
        Limited Stage SCLCFollowing concurrent platinum-based chemotherapy and radiation therapy:

        Patients with a body weight of ≥ 30 kg:

        1,500 mg every 4 weeks


        Patients with a body weight of < 30 kg:

        20 mg/kg every 4 weeks
        		Until disease progression, unacceptable toxicity, or a maximum of 24 months
        Extensive Stage SCLCPatients with a body weight of ≥ 30 kg:

        1,500 mg in combination with chemotherapy
        every 3 weeks (21 days) for 4 cycles, followed by 1,500 mg every 4 weeks as a single agent

        Patients with a body weight of < 30 kg:

        20 mg/kg in combination with chemotherapy
        every 3 weeks (21 days) for 4 cycles, followed by 10 mg/kg every 2 weeks as a single agent        		Until disease progression or until unacceptable toxicity
        BTCPatients with a body weight of ≥ 30 kg:

        1,500 mg in combination with chemotherapy
        every 3 weeks (21 days) up to 8 cycles followed by 1,500 mg every 4 weeks as a single agent

        Patients with a body weight of < 30 kg:

        20 mg/kg in combination with chemotherapy
        every 3 weeks (21 days) up to 8 cycles, followed by 20 mg/kg every 4 weeks as a single agent        		Until disease progression or until unacceptable toxicity
        uHCCPatients with a body weight of ≥ 30 kg:

        IMFINZI 1,500 mg following a single dose of tremelimumab-actlAdminister tremelimumab-actl prior to IMFINZI on the same day. When tremelimumab-actl is administered in combination with IMFINZI, refer to the Prescribing Information for tremelimumab-actl dosing information.300 mg at Day 1 of Cycle 1;

        Continue IMFINZI 1,500 mg as a single agent every 4 weeks

        Patients with a body weight of < 30 kg:

        IMFINZI 20 mg/kg following a single dose of tremelimumab-actl
        4 mg/kg at Day 1 of Cycle 1;

        Continue IMFINZI 20 mg/kg as a single agent every 4 weeks        		After Cycle 1 of combination therapy, administer IMFINZI as a single agent every 4 weeks until disease progression or unacceptable toxicity
        dMMR endometrial cancer
        Patients with a body weight of ≥ 30 kg:


        IMFINZI 1,120 mg in combination with carboplatin and paclitaxel
        every 3 weeks (21 days) for 6 cycles, followed by IMFINZI 1,500 mg every 4 weeks as a single agent


        Patients with a body weight of < 30 kg:


        IMFINZI 15 mg/kg in combination with carboplatin and paclitaxel
        every 3 weeks (21 days) for 6 cycles, followed by IMFINZI 20 mg/kg every 4 weeks as a single agent
        Until disease progression or unacceptable toxicity
        Neoadjuvant and Adjuvant Treatment of MIBC
        Patients with a body weight of ≥30 kg:


        Neoadjuvant: 1,500 mg in combination with gemcitabine and cisplatin
        every 3 weeks for 4 cycles prior to surgery


        Adjuvant: IMFINZI 1,500 mg as a single agent every 4 weeks for up to 8 cycles after surgery


        Patients with a body weight of < 30 kg:


        Neoadjuvant: 20 mg/kg in combination with gemcitabine and cisplatin
        every 3 weeks for 4 cycles prior to surgery


        Adjuvant: IMFINZI 20 mg/kg as a single agent every 4 weeks for up to 8 cycles after surgery
        Until disease progression that precludes definitive surgery, recurrence, or unacceptable toxicity or a maximum of 8 cycles after surgery
        Neoadjuvant and Adjuvant


        Treatment of Resectable


        GC/GEJC
        Patients with a body weight of ≥ 30


        kg:


        Neoadjuvant: IMFINZI 1,500 mg every 4 weeks with FLOT
        FLOT chemotherapy is administered on days 1 and 15 of each 4 week cycle
        [See Clinical Studies ]
        .
        for up to 2 cycles prior to surgery


        Adjuvant: IMFINZI 1,500 mg every 4 weeks with FLOT
        for up to 2 cycles, followed by IMFINZI 1,500 mg as a single agent every 4 weeks for up to 10 cycles


        Patients with a body weight of < 30 kg:


        Neoadjuvant: IMFINZI 20 mg/kg every 4 weeks with FLOT*± for up to 2 cycles prior to surgery


        Adjuvant: IMFINZI 20 mg/kg every 4 weeks with FLOT
        for up to 2 cycles, followed by IMFINZI 20 mg/kg as a single agent every 4 weeks for up to 10 cycles
        Neoadjuvant: Until disease progression that precludes definitive surgery or unacceptable toxicity

        IMFINZI in Combination with Tremelimumab-actl and Platinum-Based Chemotherapy

        The recommended dosage schedule and regimens for IMFINZI for the treatment of metastatic NSCLC are provided in Tables 2 and 3.

        Weigh patients prior to each infusion.

        Calculate the appropriate dose using Table 3 below based on the patient’s weight and tumor histology.

        Table 2. Recommended Dosage Schedule for Metastatic NSCLC
        Week
        continue IMFINZI until disease progression or intolerable toxicity.note the dosing interval change from every 3 weeks to every 4 weeks starting at cycle 5.
        0123456789101112131415161718192021222324
        Cycle:
        		12345678

        IMFINZI

        intravenous infusion over 60 minutes
        [see
        Dosage and Administration (2.4)
        ]
        .

        X

        X

        X

        X

        X

        X

        X

        X

        Tremelimumab-actl

        if patients receive fewer than 4 cycles of platinum-based chemotherapy, the remaining cycles of tremelimumab-actl (up to a total of 5) should be given after the platinum-based chemotherapy phase, in combination with IMFINZI, every 4 weeks.

        X

        X

        X

        X

        X

        Chemotherapy

        X

        X

        X

        X

        Xoptional pemetrexed therapy from week 12 until disease progression or intolerable toxicity for patients with non-squamous disease who received treatment with pemetrexed and carboplatin/cisplatin.

        X

        X

        X

        carboplatin & nab-paclitaxel

        OR

        carboplatin or cisplatin & pemetrexedcarboplatin & nab-paclitaxel

        OR

        carboplatin or cisplatin & gemcitabine
        Table 3. Recommended Regimen and Dosage for Metastatic NSCLC
        Tumor Histology
        Patient Weight
        IMFINZI Dosage
        Tremelimumab-actl DosageRefer to the Prescribing Information for dosing information.
        Platinum-based Chemotherapy Regimen

        Non-Squamous

        ≥ 30 kg

        1,500 mg

        75 mg

        ••

        < 30 kg

        20 mg/kg

        1 mg/kg

        Squamous

        ≥ 30 kg

        1,500 mg

        75 mg

        ••

        < 30 kg

        20 mg/kg

        1 mg/kg

        )
      • ∘Weight < 30 kg: IMFINZI 20 mg/kg every 3 weeks in combination with tremelimumab-actl 1 mg/kg and platinum-based chemotherapy, and then administer IMFINZI 20 mg/kg every 4 weeks as a single agent with histology-based pemetrexed therapy every 4 weeks, and a fifth dose of tremelimumab-actl 1 mg/kg in combination with IMFINZI dose 6 at week 16. (
        2.2 Recommended Dosage

        The recommended dosages for IMFINZI as a single agent and IMFINZI in combination with other therapeutic agents are presented in Table 1. The recommended dosage schedule and regimens for IMFINZI for the treatment of metastatic NSCLC are provided in Tables 2 and 3

        [see Indications and Usage (1.1)].

        Administer IMFINZI as a 60 minute intravenous infusion after dilution

        [ see Dosage and Administration (2.3)].

        Table 1. Recommended Dosages of IMFINZI
        Indication
        Recommended IMFINZI Dosage
        Duration of Therapy
        Neoadjuvant and Adjuvant Treatment of Resectable NSCLC
        Patients with a body weight of ≥ 30 kg:


        Neoadjuvant: IMFINZI 1,500 mg in combination with chemotherapy
        Administer IMFINZI prior to chemotherapy on the same day. Refer to the Prescribing Information for the agent administered in combination with IMFINZI for recommended dosage information, as appropriate.
        every 3 weeks for up to 4 cycles prior to surgery


        Adjuvant: IMFINZI 1,500 mg as a single agent every 4 weeks for up to 12 cycles after surgery.


        Patients with a body weight of < 30 kg:

        Neoadjuvant: IMFINZI 20 mg/kg every 3 weeks in combination with chemotherapy
        for up to 4 cycles prior to surgery.

        Adjuvant: IMFINZI 20 mg/kg every 4 weeks for up to 12 cycles as a single agent after surgery.
        Until disease progression that precludes definitive surgery, recurrence, unacceptable toxicity, or a maximum of 12 cycles after surgery
        Unresectable Stage III NSCLCFollowing concurrent platinum-based chemotherapy and radiation therapy:

        Patients with a body weight of ≥ 30 kg:

        10 mg/kg every 2 weeks

        or

        1,500 mg every 4 weeks

        Patients with a body weight of < 30 kg:

        10 mg/kg every 2 weeks        		Until disease progression, unacceptable toxicity, or a maximum of 12 months
        Limited Stage SCLCFollowing concurrent platinum-based chemotherapy and radiation therapy:

        Patients with a body weight of ≥ 30 kg:

        1,500 mg every 4 weeks


        Patients with a body weight of < 30 kg:

        20 mg/kg every 4 weeks
        		Until disease progression, unacceptable toxicity, or a maximum of 24 months
        Extensive Stage SCLCPatients with a body weight of ≥ 30 kg:

        1,500 mg in combination with chemotherapy
        every 3 weeks (21 days) for 4 cycles, followed by 1,500 mg every 4 weeks as a single agent

        Patients with a body weight of < 30 kg:

        20 mg/kg in combination with chemotherapy
        every 3 weeks (21 days) for 4 cycles, followed by 10 mg/kg every 2 weeks as a single agent        		Until disease progression or until unacceptable toxicity
        BTCPatients with a body weight of ≥ 30 kg:

        1,500 mg in combination with chemotherapy
        every 3 weeks (21 days) up to 8 cycles followed by 1,500 mg every 4 weeks as a single agent

        Patients with a body weight of < 30 kg:

        20 mg/kg in combination with chemotherapy
        every 3 weeks (21 days) up to 8 cycles, followed by 20 mg/kg every 4 weeks as a single agent        		Until disease progression or until unacceptable toxicity
        uHCCPatients with a body weight of ≥ 30 kg:

        IMFINZI 1,500 mg following a single dose of tremelimumab-actlAdminister tremelimumab-actl prior to IMFINZI on the same day. When tremelimumab-actl is administered in combination with IMFINZI, refer to the Prescribing Information for tremelimumab-actl dosing information.300 mg at Day 1 of Cycle 1;

        Continue IMFINZI 1,500 mg as a single agent every 4 weeks

        Patients with a body weight of < 30 kg:

        IMFINZI 20 mg/kg following a single dose of tremelimumab-actl
        4 mg/kg at Day 1 of Cycle 1;

        Continue IMFINZI 20 mg/kg as a single agent every 4 weeks        		After Cycle 1 of combination therapy, administer IMFINZI as a single agent every 4 weeks until disease progression or unacceptable toxicity
        dMMR endometrial cancer
        Patients with a body weight of ≥ 30 kg:


        IMFINZI 1,120 mg in combination with carboplatin and paclitaxel
        every 3 weeks (21 days) for 6 cycles, followed by IMFINZI 1,500 mg every 4 weeks as a single agent


        Patients with a body weight of < 30 kg:


        IMFINZI 15 mg/kg in combination with carboplatin and paclitaxel
        every 3 weeks (21 days) for 6 cycles, followed by IMFINZI 20 mg/kg every 4 weeks as a single agent
        Until disease progression or unacceptable toxicity
        Neoadjuvant and Adjuvant Treatment of MIBC
        Patients with a body weight of ≥30 kg:


        Neoadjuvant: 1,500 mg in combination with gemcitabine and cisplatin
        every 3 weeks for 4 cycles prior to surgery


        Adjuvant: IMFINZI 1,500 mg as a single agent every 4 weeks for up to 8 cycles after surgery


        Patients with a body weight of < 30 kg:


        Neoadjuvant: 20 mg/kg in combination with gemcitabine and cisplatin
        every 3 weeks for 4 cycles prior to surgery


        Adjuvant: IMFINZI 20 mg/kg as a single agent every 4 weeks for up to 8 cycles after surgery
        Until disease progression that precludes definitive surgery, recurrence, or unacceptable toxicity or a maximum of 8 cycles after surgery
        Neoadjuvant and Adjuvant


        Treatment of Resectable


        GC/GEJC
        Patients with a body weight of ≥ 30


        kg:


        Neoadjuvant: IMFINZI 1,500 mg every 4 weeks with FLOT
        FLOT chemotherapy is administered on days 1 and 15 of each 4 week cycle
        [See Clinical Studies ]
        .
        for up to 2 cycles prior to surgery


        Adjuvant: IMFINZI 1,500 mg every 4 weeks with FLOT
        for up to 2 cycles, followed by IMFINZI 1,500 mg as a single agent every 4 weeks for up to 10 cycles


        Patients with a body weight of < 30 kg:


        Neoadjuvant: IMFINZI 20 mg/kg every 4 weeks with FLOT*± for up to 2 cycles prior to surgery


        Adjuvant: IMFINZI 20 mg/kg every 4 weeks with FLOT
        for up to 2 cycles, followed by IMFINZI 20 mg/kg as a single agent every 4 weeks for up to 10 cycles
        Neoadjuvant: Until disease progression that precludes definitive surgery or unacceptable toxicity

        IMFINZI in Combination with Tremelimumab-actl and Platinum-Based Chemotherapy

        The recommended dosage schedule and regimens for IMFINZI for the treatment of metastatic NSCLC are provided in Tables 2 and 3.

        Weigh patients prior to each infusion.

        Calculate the appropriate dose using Table 3 below based on the patient’s weight and tumor histology.

        Table 2. Recommended Dosage Schedule for Metastatic NSCLC
        Week
        continue IMFINZI until disease progression or intolerable toxicity.note the dosing interval change from every 3 weeks to every 4 weeks starting at cycle 5.
        0123456789101112131415161718192021222324
        Cycle:
        		12345678

        IMFINZI

        intravenous infusion over 60 minutes
        [see
        Dosage and Administration (2.4)
        ]
        .

        X

        X

        X

        X

        X

        X

        X

        X

        Tremelimumab-actl

        if patients receive fewer than 4 cycles of platinum-based chemotherapy, the remaining cycles of tremelimumab-actl (up to a total of 5) should be given after the platinum-based chemotherapy phase, in combination with IMFINZI, every 4 weeks.

        X

        X

        X

        X

        X

        Chemotherapy

        X

        X

        X

        X

        Xoptional pemetrexed therapy from week 12 until disease progression or intolerable toxicity for patients with non-squamous disease who received treatment with pemetrexed and carboplatin/cisplatin.

        X

        X

        X

        carboplatin & nab-paclitaxel

        OR

        carboplatin or cisplatin & pemetrexedcarboplatin & nab-paclitaxel

        OR

        carboplatin or cisplatin & gemcitabine
        Table 3. Recommended Regimen and Dosage for Metastatic NSCLC
        Tumor Histology
        Patient Weight
        IMFINZI Dosage
        Tremelimumab-actl DosageRefer to the Prescribing Information for dosing information.
        Platinum-based Chemotherapy Regimen

        Non-Squamous

        ≥ 30 kg

        1,500 mg

        75 mg

        ••

        < 30 kg

        20 mg/kg

        1 mg/kg

        Squamous

        ≥ 30 kg

        1,500 mg

        75 mg

        ••

        < 30 kg

        20 mg/kg

        1 mg/kg

        )
    • •LS-SCLC, following concurrent platinum-based chemotherapy and radiation therapy:
      • ∘Weight ≥ 30 kg: 1,500 mg every 4 weeks. (
        2.2 Recommended Dosage

        The recommended dosages for IMFINZI as a single agent and IMFINZI in combination with other therapeutic agents are presented in Table 1. The recommended dosage schedule and regimens for IMFINZI for the treatment of metastatic NSCLC are provided in Tables 2 and 3

        [see Indications and Usage (1.1)].

        Administer IMFINZI as a 60 minute intravenous infusion after dilution

        [ see Dosage and Administration (2.3)].

        Table 1. Recommended Dosages of IMFINZI
        Indication
        Recommended IMFINZI Dosage
        Duration of Therapy
        Neoadjuvant and Adjuvant Treatment of Resectable NSCLC
        Patients with a body weight of ≥ 30 kg:


        Neoadjuvant: IMFINZI 1,500 mg in combination with chemotherapy
        Administer IMFINZI prior to chemotherapy on the same day. Refer to the Prescribing Information for the agent administered in combination with IMFINZI for recommended dosage information, as appropriate.
        every 3 weeks for up to 4 cycles prior to surgery


        Adjuvant: IMFINZI 1,500 mg as a single agent every 4 weeks for up to 12 cycles after surgery.


        Patients with a body weight of < 30 kg:

        Neoadjuvant: IMFINZI 20 mg/kg every 3 weeks in combination with chemotherapy
        for up to 4 cycles prior to surgery.

        Adjuvant: IMFINZI 20 mg/kg every 4 weeks for up to 12 cycles as a single agent after surgery.
        Until disease progression that precludes definitive surgery, recurrence, unacceptable toxicity, or a maximum of 12 cycles after surgery
        Unresectable Stage III NSCLCFollowing concurrent platinum-based chemotherapy and radiation therapy:

        Patients with a body weight of ≥ 30 kg:

        10 mg/kg every 2 weeks

        or

        1,500 mg every 4 weeks

        Patients with a body weight of < 30 kg:

        10 mg/kg every 2 weeks        		Until disease progression, unacceptable toxicity, or a maximum of 12 months
        Limited Stage SCLCFollowing concurrent platinum-based chemotherapy and radiation therapy:

        Patients with a body weight of ≥ 30 kg:

        1,500 mg every 4 weeks


        Patients with a body weight of < 30 kg:

        20 mg/kg every 4 weeks
        		Until disease progression, unacceptable toxicity, or a maximum of 24 months
        Extensive Stage SCLCPatients with a body weight of ≥ 30 kg:

        1,500 mg in combination with chemotherapy
        every 3 weeks (21 days) for 4 cycles, followed by 1,500 mg every 4 weeks as a single agent

        Patients with a body weight of < 30 kg:

        20 mg/kg in combination with chemotherapy
        every 3 weeks (21 days) for 4 cycles, followed by 10 mg/kg every 2 weeks as a single agent        		Until disease progression or until unacceptable toxicity
        BTCPatients with a body weight of ≥ 30 kg:

        1,500 mg in combination with chemotherapy
        every 3 weeks (21 days) up to 8 cycles followed by 1,500 mg every 4 weeks as a single agent

        Patients with a body weight of < 30 kg:

        20 mg/kg in combination with chemotherapy
        every 3 weeks (21 days) up to 8 cycles, followed by 20 mg/kg every 4 weeks as a single agent        		Until disease progression or until unacceptable toxicity
        uHCCPatients with a body weight of ≥ 30 kg:

        IMFINZI 1,500 mg following a single dose of tremelimumab-actlAdminister tremelimumab-actl prior to IMFINZI on the same day. When tremelimumab-actl is administered in combination with IMFINZI, refer to the Prescribing Information for tremelimumab-actl dosing information.300 mg at Day 1 of Cycle 1;

        Continue IMFINZI 1,500 mg as a single agent every 4 weeks

        Patients with a body weight of < 30 kg:

        IMFINZI 20 mg/kg following a single dose of tremelimumab-actl
        4 mg/kg at Day 1 of Cycle 1;

        Continue IMFINZI 20 mg/kg as a single agent every 4 weeks        		After Cycle 1 of combination therapy, administer IMFINZI as a single agent every 4 weeks until disease progression or unacceptable toxicity
        dMMR endometrial cancer
        Patients with a body weight of ≥ 30 kg:


        IMFINZI 1,120 mg in combination with carboplatin and paclitaxel
        every 3 weeks (21 days) for 6 cycles, followed by IMFINZI 1,500 mg every 4 weeks as a single agent


        Patients with a body weight of < 30 kg:


        IMFINZI 15 mg/kg in combination with carboplatin and paclitaxel
        every 3 weeks (21 days) for 6 cycles, followed by IMFINZI 20 mg/kg every 4 weeks as a single agent
        Until disease progression or unacceptable toxicity
        Neoadjuvant and Adjuvant Treatment of MIBC
        Patients with a body weight of ≥30 kg:


        Neoadjuvant: 1,500 mg in combination with gemcitabine and cisplatin
        every 3 weeks for 4 cycles prior to surgery


        Adjuvant: IMFINZI 1,500 mg as a single agent every 4 weeks for up to 8 cycles after surgery


        Patients with a body weight of < 30 kg:


        Neoadjuvant: 20 mg/kg in combination with gemcitabine and cisplatin
        every 3 weeks for 4 cycles prior to surgery


        Adjuvant: IMFINZI 20 mg/kg as a single agent every 4 weeks for up to 8 cycles after surgery
        Until disease progression that precludes definitive surgery, recurrence, or unacceptable toxicity or a maximum of 8 cycles after surgery
        Neoadjuvant and Adjuvant


        Treatment of Resectable


        GC/GEJC
        Patients with a body weight of ≥ 30


        kg:


        Neoadjuvant: IMFINZI 1,500 mg every 4 weeks with FLOT
        FLOT chemotherapy is administered on days 1 and 15 of each 4 week cycle
        [See Clinical Studies ]
        .
        for up to 2 cycles prior to surgery


        Adjuvant: IMFINZI 1,500 mg every 4 weeks with FLOT
        for up to 2 cycles, followed by IMFINZI 1,500 mg as a single agent every 4 weeks for up to 10 cycles


        Patients with a body weight of < 30 kg:


        Neoadjuvant: IMFINZI 20 mg/kg every 4 weeks with FLOT*± for up to 2 cycles prior to surgery


        Adjuvant: IMFINZI 20 mg/kg every 4 weeks with FLOT
        for up to 2 cycles, followed by IMFINZI 20 mg/kg as a single agent every 4 weeks for up to 10 cycles
        Neoadjuvant: Until disease progression that precludes definitive surgery or unacceptable toxicity

        IMFINZI in Combination with Tremelimumab-actl and Platinum-Based Chemotherapy

        The recommended dosage schedule and regimens for IMFINZI for the treatment of metastatic NSCLC are provided in Tables 2 and 3.

        Weigh patients prior to each infusion.

        Calculate the appropriate dose using Table 3 below based on the patient’s weight and tumor histology.

        Table 2. Recommended Dosage Schedule for Metastatic NSCLC
        Week
        continue IMFINZI until disease progression or intolerable toxicity.note the dosing interval change from every 3 weeks to every 4 weeks starting at cycle 5.
        0123456789101112131415161718192021222324
        Cycle:
        		12345678

        IMFINZI

        intravenous infusion over 60 minutes
        [see
        Dosage and Administration (2.4)
        ]
        .

        X

        X

        X

        X

        X

        X

        X

        X

        Tremelimumab-actl

        if patients receive fewer than 4 cycles of platinum-based chemotherapy, the remaining cycles of tremelimumab-actl (up to a total of 5) should be given after the platinum-based chemotherapy phase, in combination with IMFINZI, every 4 weeks.

        X

        X

        X

        X

        X

        Chemotherapy

        X

        X

        X

        X

        Xoptional pemetrexed therapy from week 12 until disease progression or intolerable toxicity for patients with non-squamous disease who received treatment with pemetrexed and carboplatin/cisplatin.

        X

        X

        X

        carboplatin & nab-paclitaxel

        OR

        carboplatin or cisplatin & pemetrexedcarboplatin & nab-paclitaxel

        OR

        carboplatin or cisplatin & gemcitabine
        Table 3. Recommended Regimen and Dosage for Metastatic NSCLC
        Tumor Histology
        Patient Weight
        IMFINZI Dosage
        Tremelimumab-actl DosageRefer to the Prescribing Information for dosing information.
        Platinum-based Chemotherapy Regimen

        Non-Squamous

        ≥ 30 kg

        1,500 mg

        75 mg

        ••

        < 30 kg

        20 mg/kg

        1 mg/kg

        Squamous

        ≥ 30 kg

        1,500 mg

        75 mg

        ••

        < 30 kg

        20 mg/kg

        1 mg/kg

        )
      • ∘Weight < 30 kg: 20 mg/kg every 4 weeks. (
        2.2 Recommended Dosage

        The recommended dosages for IMFINZI as a single agent and IMFINZI in combination with other therapeutic agents are presented in Table 1. The recommended dosage schedule and regimens for IMFINZI for the treatment of metastatic NSCLC are provided in Tables 2 and 3

        [see Indications and Usage (1.1)].

        Administer IMFINZI as a 60 minute intravenous infusion after dilution

        [ see Dosage and Administration (2.3)].

        Table 1. Recommended Dosages of IMFINZI
        Indication
        Recommended IMFINZI Dosage
        Duration of Therapy
        Neoadjuvant and Adjuvant Treatment of Resectable NSCLC
        Patients with a body weight of ≥ 30 kg:


        Neoadjuvant: IMFINZI 1,500 mg in combination with chemotherapy
        Administer IMFINZI prior to chemotherapy on the same day. Refer to the Prescribing Information for the agent administered in combination with IMFINZI for recommended dosage information, as appropriate.
        every 3 weeks for up to 4 cycles prior to surgery


        Adjuvant: IMFINZI 1,500 mg as a single agent every 4 weeks for up to 12 cycles after surgery.


        Patients with a body weight of < 30 kg:

        Neoadjuvant: IMFINZI 20 mg/kg every 3 weeks in combination with chemotherapy
        for up to 4 cycles prior to surgery.

        Adjuvant: IMFINZI 20 mg/kg every 4 weeks for up to 12 cycles as a single agent after surgery.
        Until disease progression that precludes definitive surgery, recurrence, unacceptable toxicity, or a maximum of 12 cycles after surgery
        Unresectable Stage III NSCLCFollowing concurrent platinum-based chemotherapy and radiation therapy:

        Patients with a body weight of ≥ 30 kg:

        10 mg/kg every 2 weeks

        or

        1,500 mg every 4 weeks

        Patients with a body weight of < 30 kg:

        10 mg/kg every 2 weeks        		Until disease progression, unacceptable toxicity, or a maximum of 12 months
        Limited Stage SCLCFollowing concurrent platinum-based chemotherapy and radiation therapy:

        Patients with a body weight of ≥ 30 kg:

        1,500 mg every 4 weeks


        Patients with a body weight of < 30 kg:

        20 mg/kg every 4 weeks
        		Until disease progression, unacceptable toxicity, or a maximum of 24 months
        Extensive Stage SCLCPatients with a body weight of ≥ 30 kg:

        1,500 mg in combination with chemotherapy
        every 3 weeks (21 days) for 4 cycles, followed by 1,500 mg every 4 weeks as a single agent

        Patients with a body weight of < 30 kg:

        20 mg/kg in combination with chemotherapy
        every 3 weeks (21 days) for 4 cycles, followed by 10 mg/kg every 2 weeks as a single agent        		Until disease progression or until unacceptable toxicity
        BTCPatients with a body weight of ≥ 30 kg:

        1,500 mg in combination with chemotherapy
        every 3 weeks (21 days) up to 8 cycles followed by 1,500 mg every 4 weeks as a single agent

        Patients with a body weight of < 30 kg:

        20 mg/kg in combination with chemotherapy
        every 3 weeks (21 days) up to 8 cycles, followed by 20 mg/kg every 4 weeks as a single agent        		Until disease progression or until unacceptable toxicity
        uHCCPatients with a body weight of ≥ 30 kg:

        IMFINZI 1,500 mg following a single dose of tremelimumab-actlAdminister tremelimumab-actl prior to IMFINZI on the same day. When tremelimumab-actl is administered in combination with IMFINZI, refer to the Prescribing Information for tremelimumab-actl dosing information.300 mg at Day 1 of Cycle 1;

        Continue IMFINZI 1,500 mg as a single agent every 4 weeks

        Patients with a body weight of < 30 kg:

        IMFINZI 20 mg/kg following a single dose of tremelimumab-actl
        4 mg/kg at Day 1 of Cycle 1;

        Continue IMFINZI 20 mg/kg as a single agent every 4 weeks        		After Cycle 1 of combination therapy, administer IMFINZI as a single agent every 4 weeks until disease progression or unacceptable toxicity
        dMMR endometrial cancer
        Patients with a body weight of ≥ 30 kg:


        IMFINZI 1,120 mg in combination with carboplatin and paclitaxel
        every 3 weeks (21 days) for 6 cycles, followed by IMFINZI 1,500 mg every 4 weeks as a single agent


        Patients with a body weight of < 30 kg:


        IMFINZI 15 mg/kg in combination with carboplatin and paclitaxel
        every 3 weeks (21 days) for 6 cycles, followed by IMFINZI 20 mg/kg every 4 weeks as a single agent
        Until disease progression or unacceptable toxicity
        Neoadjuvant and Adjuvant Treatment of MIBC
        Patients with a body weight of ≥30 kg:


        Neoadjuvant: 1,500 mg in combination with gemcitabine and cisplatin
        every 3 weeks for 4 cycles prior to surgery


        Adjuvant: IMFINZI 1,500 mg as a single agent every 4 weeks for up to 8 cycles after surgery


        Patients with a body weight of < 30 kg:


        Neoadjuvant: 20 mg/kg in combination with gemcitabine and cisplatin
        every 3 weeks for 4 cycles prior to surgery


        Adjuvant: IMFINZI 20 mg/kg as a single agent every 4 weeks for up to 8 cycles after surgery
        Until disease progression that precludes definitive surgery, recurrence, or unacceptable toxicity or a maximum of 8 cycles after surgery
        Neoadjuvant and Adjuvant


        Treatment of Resectable


        GC/GEJC
        Patients with a body weight of ≥ 30


        kg:


        Neoadjuvant: IMFINZI 1,500 mg every 4 weeks with FLOT
        FLOT chemotherapy is administered on days 1 and 15 of each 4 week cycle
        [See Clinical Studies ]
        .
        for up to 2 cycles prior to surgery


        Adjuvant: IMFINZI 1,500 mg every 4 weeks with FLOT
        for up to 2 cycles, followed by IMFINZI 1,500 mg as a single agent every 4 weeks for up to 10 cycles


        Patients with a body weight of < 30 kg:


        Neoadjuvant: IMFINZI 20 mg/kg every 4 weeks with FLOT*± for up to 2 cycles prior to surgery


        Adjuvant: IMFINZI 20 mg/kg every 4 weeks with FLOT
        for up to 2 cycles, followed by IMFINZI 20 mg/kg as a single agent every 4 weeks for up to 10 cycles
        Neoadjuvant: Until disease progression that precludes definitive surgery or unacceptable toxicity

        IMFINZI in Combination with Tremelimumab-actl and Platinum-Based Chemotherapy

        The recommended dosage schedule and regimens for IMFINZI for the treatment of metastatic NSCLC are provided in Tables 2 and 3.

        Weigh patients prior to each infusion.

        Calculate the appropriate dose using Table 3 below based on the patient’s weight and tumor histology.

        Table 2. Recommended Dosage Schedule for Metastatic NSCLC
        Week
        continue IMFINZI until disease progression or intolerable toxicity.note the dosing interval change from every 3 weeks to every 4 weeks starting at cycle 5.
        0123456789101112131415161718192021222324
        Cycle:
        		12345678

        IMFINZI

        intravenous infusion over 60 minutes
        [see
        Dosage and Administration (2.4)
        ]
        .

        X

        X

        X

        X

        X

        X

        X

        X

        Tremelimumab-actl

        if patients receive fewer than 4 cycles of platinum-based chemotherapy, the remaining cycles of tremelimumab-actl (up to a total of 5) should be given after the platinum-based chemotherapy phase, in combination with IMFINZI, every 4 weeks.

        X

        X

        X

        X

        X

        Chemotherapy

        X

        X

        X

        X

        Xoptional pemetrexed therapy from week 12 until disease progression or intolerable toxicity for patients with non-squamous disease who received treatment with pemetrexed and carboplatin/cisplatin.

        X

        X

        X

        carboplatin & nab-paclitaxel

        OR

        carboplatin or cisplatin & pemetrexedcarboplatin & nab-paclitaxel

        OR

        carboplatin or cisplatin & gemcitabine
        Table 3. Recommended Regimen and Dosage for Metastatic NSCLC
        Tumor Histology
        Patient Weight
        IMFINZI Dosage
        Tremelimumab-actl DosageRefer to the Prescribing Information for dosing information.
        Platinum-based Chemotherapy Regimen

        Non-Squamous

        ≥ 30 kg

        1,500 mg

        75 mg

        ••

        < 30 kg

        20 mg/kg

        1 mg/kg

        Squamous

        ≥ 30 kg

        1,500 mg

        75 mg

        ••

        < 30 kg

        20 mg/kg

        1 mg/kg

        )
    • •ES-SCLC:
      • ∘Weight ≥ 30 kg: With etoposide and either carboplatin or cisplatin, administer IMFINZI 1,500 mg every 3 weeks in combination with chemotherapy, and then 1,500 mg every 4 weeks as a single agent. (
        2.2 Recommended Dosage

        The recommended dosages for IMFINZI as a single agent and IMFINZI in combination with other therapeutic agents are presented in Table 1. The recommended dosage schedule and regimens for IMFINZI for the treatment of metastatic NSCLC are provided in Tables 2 and 3

        [see Indications and Usage (1.1)].

        Administer IMFINZI as a 60 minute intravenous infusion after dilution

        [ see Dosage and Administration (2.3)].

        Table 1. Recommended Dosages of IMFINZI
        Indication
        Recommended IMFINZI Dosage
        Duration of Therapy
        Neoadjuvant and Adjuvant Treatment of Resectable NSCLC
        Patients with a body weight of ≥ 30 kg:


        Neoadjuvant: IMFINZI 1,500 mg in combination with chemotherapy
        Administer IMFINZI prior to chemotherapy on the same day. Refer to the Prescribing Information for the agent administered in combination with IMFINZI for recommended dosage information, as appropriate.
        every 3 weeks for up to 4 cycles prior to surgery


        Adjuvant: IMFINZI 1,500 mg as a single agent every 4 weeks for up to 12 cycles after surgery.


        Patients with a body weight of < 30 kg:

        Neoadjuvant: IMFINZI 20 mg/kg every 3 weeks in combination with chemotherapy
        for up to 4 cycles prior to surgery.

        Adjuvant: IMFINZI 20 mg/kg every 4 weeks for up to 12 cycles as a single agent after surgery.
        Until disease progression that precludes definitive surgery, recurrence, unacceptable toxicity, or a maximum of 12 cycles after surgery
        Unresectable Stage III NSCLCFollowing concurrent platinum-based chemotherapy and radiation therapy:

        Patients with a body weight of ≥ 30 kg:

        10 mg/kg every 2 weeks

        or

        1,500 mg every 4 weeks

        Patients with a body weight of < 30 kg:

        10 mg/kg every 2 weeks        		Until disease progression, unacceptable toxicity, or a maximum of 12 months
        Limited Stage SCLCFollowing concurrent platinum-based chemotherapy and radiation therapy:

        Patients with a body weight of ≥ 30 kg:

        1,500 mg every 4 weeks


        Patients with a body weight of < 30 kg:

        20 mg/kg every 4 weeks
        		Until disease progression, unacceptable toxicity, or a maximum of 24 months
        Extensive Stage SCLCPatients with a body weight of ≥ 30 kg:

        1,500 mg in combination with chemotherapy
        every 3 weeks (21 days) for 4 cycles, followed by 1,500 mg every 4 weeks as a single agent

        Patients with a body weight of < 30 kg:

        20 mg/kg in combination with chemotherapy
        every 3 weeks (21 days) for 4 cycles, followed by 10 mg/kg every 2 weeks as a single agent        		Until disease progression or until unacceptable toxicity
        BTCPatients with a body weight of ≥ 30 kg:

        1,500 mg in combination with chemotherapy
        every 3 weeks (21 days) up to 8 cycles followed by 1,500 mg every 4 weeks as a single agent

        Patients with a body weight of < 30 kg:

        20 mg/kg in combination with chemotherapy
        every 3 weeks (21 days) up to 8 cycles, followed by 20 mg/kg every 4 weeks as a single agent        		Until disease progression or until unacceptable toxicity
        uHCCPatients with a body weight of ≥ 30 kg:

        IMFINZI 1,500 mg following a single dose of tremelimumab-actlAdminister tremelimumab-actl prior to IMFINZI on the same day. When tremelimumab-actl is administered in combination with IMFINZI, refer to the Prescribing Information for tremelimumab-actl dosing information.300 mg at Day 1 of Cycle 1;

        Continue IMFINZI 1,500 mg as a single agent every 4 weeks

        Patients with a body weight of < 30 kg:

        IMFINZI 20 mg/kg following a single dose of tremelimumab-actl
        4 mg/kg at Day 1 of Cycle 1;

        Continue IMFINZI 20 mg/kg as a single agent every 4 weeks        		After Cycle 1 of combination therapy, administer IMFINZI as a single agent every 4 weeks until disease progression or unacceptable toxicity
        dMMR endometrial cancer
        Patients with a body weight of ≥ 30 kg:


        IMFINZI 1,120 mg in combination with carboplatin and paclitaxel
        every 3 weeks (21 days) for 6 cycles, followed by IMFINZI 1,500 mg every 4 weeks as a single agent


        Patients with a body weight of < 30 kg:


        IMFINZI 15 mg/kg in combination with carboplatin and paclitaxel
        every 3 weeks (21 days) for 6 cycles, followed by IMFINZI 20 mg/kg every 4 weeks as a single agent
        Until disease progression or unacceptable toxicity
        Neoadjuvant and Adjuvant Treatment of MIBC
        Patients with a body weight of ≥30 kg:


        Neoadjuvant: 1,500 mg in combination with gemcitabine and cisplatin
        every 3 weeks for 4 cycles prior to surgery


        Adjuvant: IMFINZI 1,500 mg as a single agent every 4 weeks for up to 8 cycles after surgery


        Patients with a body weight of < 30 kg:


        Neoadjuvant: 20 mg/kg in combination with gemcitabine and cisplatin
        every 3 weeks for 4 cycles prior to surgery


        Adjuvant: IMFINZI 20 mg/kg as a single agent every 4 weeks for up to 8 cycles after surgery
        Until disease progression that precludes definitive surgery, recurrence, or unacceptable toxicity or a maximum of 8 cycles after surgery
        Neoadjuvant and Adjuvant


        Treatment of Resectable


        GC/GEJC
        Patients with a body weight of ≥ 30


        kg:


        Neoadjuvant: IMFINZI 1,500 mg every 4 weeks with FLOT
        FLOT chemotherapy is administered on days 1 and 15 of each 4 week cycle
        [See Clinical Studies ]
        .
        for up to 2 cycles prior to surgery


        Adjuvant: IMFINZI 1,500 mg every 4 weeks with FLOT
        for up to 2 cycles, followed by IMFINZI 1,500 mg as a single agent every 4 weeks for up to 10 cycles


        Patients with a body weight of < 30 kg:


        Neoadjuvant: IMFINZI 20 mg/kg every 4 weeks with FLOT*± for up to 2 cycles prior to surgery


        Adjuvant: IMFINZI 20 mg/kg every 4 weeks with FLOT
        for up to 2 cycles, followed by IMFINZI 20 mg/kg as a single agent every 4 weeks for up to 10 cycles
        Neoadjuvant: Until disease progression that precludes definitive surgery or unacceptable toxicity

        IMFINZI in Combination with Tremelimumab-actl and Platinum-Based Chemotherapy

        The recommended dosage schedule and regimens for IMFINZI for the treatment of metastatic NSCLC are provided in Tables 2 and 3.

        Weigh patients prior to each infusion.

        Calculate the appropriate dose using Table 3 below based on the patient’s weight and tumor histology.

        Table 2. Recommended Dosage Schedule for Metastatic NSCLC
        Week
        continue IMFINZI until disease progression or intolerable toxicity.note the dosing interval change from every 3 weeks to every 4 weeks starting at cycle 5.
        0123456789101112131415161718192021222324
        Cycle:
        		12345678

        IMFINZI

        intravenous infusion over 60 minutes
        [see
        Dosage and Administration (2.4)
        ]
        .

        X

        X

        X

        X

        X

        X

        X

        X

        Tremelimumab-actl

        if patients receive fewer than 4 cycles of platinum-based chemotherapy, the remaining cycles of tremelimumab-actl (up to a total of 5) should be given after the platinum-based chemotherapy phase, in combination with IMFINZI, every 4 weeks.

        X

        X

        X

        X

        X

        Chemotherapy

        X

        X

        X

        X

        Xoptional pemetrexed therapy from week 12 until disease progression or intolerable toxicity for patients with non-squamous disease who received treatment with pemetrexed and carboplatin/cisplatin.

        X

        X

        X

        carboplatin & nab-paclitaxel

        OR

        carboplatin or cisplatin & pemetrexedcarboplatin & nab-paclitaxel

        OR

        carboplatin or cisplatin & gemcitabine
        Table 3. Recommended Regimen and Dosage for Metastatic NSCLC
        Tumor Histology
        Patient Weight
        IMFINZI Dosage
        Tremelimumab-actl DosageRefer to the Prescribing Information for dosing information.
        Platinum-based Chemotherapy Regimen

        Non-Squamous

        ≥ 30 kg

        1,500 mg

        75 mg

        ••

        < 30 kg

        20 mg/kg

        1 mg/kg

        Squamous

        ≥ 30 kg

        1,500 mg

        75 mg

        ••

        < 30 kg

        20 mg/kg

        1 mg/kg

        )
      • ∘Weight < 30 kg: With etoposide and either carboplatin or cisplatin, administer IMFINZI 20 mg/kg every 3 weeks in combination with chemotherapy, and then 10 mg/kg every 2 weeks as a single agent. (
        2.2 Recommended Dosage

        The recommended dosages for IMFINZI as a single agent and IMFINZI in combination with other therapeutic agents are presented in Table 1. The recommended dosage schedule and regimens for IMFINZI for the treatment of metastatic NSCLC are provided in Tables 2 and 3

        [see Indications and Usage (1.1)].

        Administer IMFINZI as a 60 minute intravenous infusion after dilution

        [ see Dosage and Administration (2.3)].

        Table 1. Recommended Dosages of IMFINZI
        Indication
        Recommended IMFINZI Dosage
        Duration of Therapy
        Neoadjuvant and Adjuvant Treatment of Resectable NSCLC
        Patients with a body weight of ≥ 30 kg:


        Neoadjuvant: IMFINZI 1,500 mg in combination with chemotherapy
        Administer IMFINZI prior to chemotherapy on the same day. Refer to the Prescribing Information for the agent administered in combination with IMFINZI for recommended dosage information, as appropriate.
        every 3 weeks for up to 4 cycles prior to surgery


        Adjuvant: IMFINZI 1,500 mg as a single agent every 4 weeks for up to 12 cycles after surgery.


        Patients with a body weight of < 30 kg:

        Neoadjuvant: IMFINZI 20 mg/kg every 3 weeks in combination with chemotherapy
        for up to 4 cycles prior to surgery.

        Adjuvant: IMFINZI 20 mg/kg every 4 weeks for up to 12 cycles as a single agent after surgery.
        Until disease progression that precludes definitive surgery, recurrence, unacceptable toxicity, or a maximum of 12 cycles after surgery
        Unresectable Stage III NSCLCFollowing concurrent platinum-based chemotherapy and radiation therapy:

        Patients with a body weight of ≥ 30 kg:

        10 mg/kg every 2 weeks

        or

        1,500 mg every 4 weeks

        Patients with a body weight of < 30 kg:

        10 mg/kg every 2 weeks        		Until disease progression, unacceptable toxicity, or a maximum of 12 months
        Limited Stage SCLCFollowing concurrent platinum-based chemotherapy and radiation therapy:

        Patients with a body weight of ≥ 30 kg:

        1,500 mg every 4 weeks


        Patients with a body weight of < 30 kg:

        20 mg/kg every 4 weeks
        		Until disease progression, unacceptable toxicity, or a maximum of 24 months
        Extensive Stage SCLCPatients with a body weight of ≥ 30 kg:

        1,500 mg in combination with chemotherapy
        every 3 weeks (21 days) for 4 cycles, followed by 1,500 mg every 4 weeks as a single agent

        Patients with a body weight of < 30 kg:

        20 mg/kg in combination with chemotherapy
        every 3 weeks (21 days) for 4 cycles, followed by 10 mg/kg every 2 weeks as a single agent        		Until disease progression or until unacceptable toxicity
        BTCPatients with a body weight of ≥ 30 kg:

        1,500 mg in combination with chemotherapy
        every 3 weeks (21 days) up to 8 cycles followed by 1,500 mg every 4 weeks as a single agent

        Patients with a body weight of < 30 kg:

        20 mg/kg in combination with chemotherapy
        every 3 weeks (21 days) up to 8 cycles, followed by 20 mg/kg every 4 weeks as a single agent        		Until disease progression or until unacceptable toxicity
        uHCCPatients with a body weight of ≥ 30 kg:

        IMFINZI 1,500 mg following a single dose of tremelimumab-actlAdminister tremelimumab-actl prior to IMFINZI on the same day. When tremelimumab-actl is administered in combination with IMFINZI, refer to the Prescribing Information for tremelimumab-actl dosing information.300 mg at Day 1 of Cycle 1;

        Continue IMFINZI 1,500 mg as a single agent every 4 weeks

        Patients with a body weight of < 30 kg:

        IMFINZI 20 mg/kg following a single dose of tremelimumab-actl
        4 mg/kg at Day 1 of Cycle 1;

        Continue IMFINZI 20 mg/kg as a single agent every 4 weeks        		After Cycle 1 of combination therapy, administer IMFINZI as a single agent every 4 weeks until disease progression or unacceptable toxicity
        dMMR endometrial cancer
        Patients with a body weight of ≥ 30 kg:


        IMFINZI 1,120 mg in combination with carboplatin and paclitaxel
        every 3 weeks (21 days) for 6 cycles, followed by IMFINZI 1,500 mg every 4 weeks as a single agent


        Patients with a body weight of < 30 kg:


        IMFINZI 15 mg/kg in combination with carboplatin and paclitaxel
        every 3 weeks (21 days) for 6 cycles, followed by IMFINZI 20 mg/kg every 4 weeks as a single agent
        Until disease progression or unacceptable toxicity
        Neoadjuvant and Adjuvant Treatment of MIBC
        Patients with a body weight of ≥30 kg:


        Neoadjuvant: 1,500 mg in combination with gemcitabine and cisplatin
        every 3 weeks for 4 cycles prior to surgery


        Adjuvant: IMFINZI 1,500 mg as a single agent every 4 weeks for up to 8 cycles after surgery


        Patients with a body weight of < 30 kg:


        Neoadjuvant: 20 mg/kg in combination with gemcitabine and cisplatin
        every 3 weeks for 4 cycles prior to surgery


        Adjuvant: IMFINZI 20 mg/kg as a single agent every 4 weeks for up to 8 cycles after surgery
        Until disease progression that precludes definitive surgery, recurrence, or unacceptable toxicity or a maximum of 8 cycles after surgery
        Neoadjuvant and Adjuvant


        Treatment of Resectable


        GC/GEJC
        Patients with a body weight of ≥ 30


        kg:


        Neoadjuvant: IMFINZI 1,500 mg every 4 weeks with FLOT
        FLOT chemotherapy is administered on days 1 and 15 of each 4 week cycle
        [See Clinical Studies ]
        .
        for up to 2 cycles prior to surgery


        Adjuvant: IMFINZI 1,500 mg every 4 weeks with FLOT
        for up to 2 cycles, followed by IMFINZI 1,500 mg as a single agent every 4 weeks for up to 10 cycles


        Patients with a body weight of < 30 kg:


        Neoadjuvant: IMFINZI 20 mg/kg every 4 weeks with FLOT*± for up to 2 cycles prior to surgery


        Adjuvant: IMFINZI 20 mg/kg every 4 weeks with FLOT
        for up to 2 cycles, followed by IMFINZI 20 mg/kg as a single agent every 4 weeks for up to 10 cycles
        Neoadjuvant: Until disease progression that precludes definitive surgery or unacceptable toxicity

        IMFINZI in Combination with Tremelimumab-actl and Platinum-Based Chemotherapy

        The recommended dosage schedule and regimens for IMFINZI for the treatment of metastatic NSCLC are provided in Tables 2 and 3.

        Weigh patients prior to each infusion.

        Calculate the appropriate dose using Table 3 below based on the patient’s weight and tumor histology.

        Table 2. Recommended Dosage Schedule for Metastatic NSCLC
        Week
        continue IMFINZI until disease progression or intolerable toxicity.note the dosing interval change from every 3 weeks to every 4 weeks starting at cycle 5.
        0123456789101112131415161718192021222324
        Cycle:
        		12345678

        IMFINZI

        intravenous infusion over 60 minutes
        [see
        Dosage and Administration (2.4)
        ]
        .

        X

        X

        X

        X

        X

        X

        X

        X

        Tremelimumab-actl

        if patients receive fewer than 4 cycles of platinum-based chemotherapy, the remaining cycles of tremelimumab-actl (up to a total of 5) should be given after the platinum-based chemotherapy phase, in combination with IMFINZI, every 4 weeks.

        X

        X

        X

        X

        X

        Chemotherapy

        X

        X

        X

        X

        Xoptional pemetrexed therapy from week 12 until disease progression or intolerable toxicity for patients with non-squamous disease who received treatment with pemetrexed and carboplatin/cisplatin.

        X

        X

        X

        carboplatin & nab-paclitaxel

        OR

        carboplatin or cisplatin & pemetrexedcarboplatin & nab-paclitaxel

        OR

        carboplatin or cisplatin & gemcitabine
        Table 3. Recommended Regimen and Dosage for Metastatic NSCLC
        Tumor Histology
        Patient Weight
        IMFINZI Dosage
        Tremelimumab-actl DosageRefer to the Prescribing Information for dosing information.
        Platinum-based Chemotherapy Regimen

        Non-Squamous

        ≥ 30 kg

        1,500 mg

        75 mg

        ••

        < 30 kg

        20 mg/kg

        1 mg/kg

        Squamous

        ≥ 30 kg

        1,500 mg

        75 mg

        ••

        < 30 kg

        20 mg/kg

        1 mg/kg

        )
    • •BTC:
      • ∘Weight ≥ 30 kg: administer IMFINZI 1,500 mg every 3 weeks in combination with chemotherapy, and then 1,500 mg every 4 weeks as a single agent. (
        2.2 Recommended Dosage

        The recommended dosages for IMFINZI as a single agent and IMFINZI in combination with other therapeutic agents are presented in Table 1. The recommended dosage schedule and regimens for IMFINZI for the treatment of metastatic NSCLC are provided in Tables 2 and 3

        [see Indications and Usage (1.1)].

        Administer IMFINZI as a 60 minute intravenous infusion after dilution

        [ see Dosage and Administration (2.3)].

        Table 1. Recommended Dosages of IMFINZI
        Indication
        Recommended IMFINZI Dosage
        Duration of Therapy
        Neoadjuvant and Adjuvant Treatment of Resectable NSCLC
        Patients with a body weight of ≥ 30 kg:


        Neoadjuvant: IMFINZI 1,500 mg in combination with chemotherapy
        Administer IMFINZI prior to chemotherapy on the same day. Refer to the Prescribing Information for the agent administered in combination with IMFINZI for recommended dosage information, as appropriate.
        every 3 weeks for up to 4 cycles prior to surgery


        Adjuvant: IMFINZI 1,500 mg as a single agent every 4 weeks for up to 12 cycles after surgery.


        Patients with a body weight of < 30 kg:

        Neoadjuvant: IMFINZI 20 mg/kg every 3 weeks in combination with chemotherapy
        for up to 4 cycles prior to surgery.

        Adjuvant: IMFINZI 20 mg/kg every 4 weeks for up to 12 cycles as a single agent after surgery.
        Until disease progression that precludes definitive surgery, recurrence, unacceptable toxicity, or a maximum of 12 cycles after surgery
        Unresectable Stage III NSCLCFollowing concurrent platinum-based chemotherapy and radiation therapy:

        Patients with a body weight of ≥ 30 kg:

        10 mg/kg every 2 weeks

        or

        1,500 mg every 4 weeks

        Patients with a body weight of < 30 kg:

        10 mg/kg every 2 weeks        		Until disease progression, unacceptable toxicity, or a maximum of 12 months
        Limited Stage SCLCFollowing concurrent platinum-based chemotherapy and radiation therapy:

        Patients with a body weight of ≥ 30 kg:

        1,500 mg every 4 weeks


        Patients with a body weight of < 30 kg:

        20 mg/kg every 4 weeks
        		Until disease progression, unacceptable toxicity, or a maximum of 24 months
        Extensive Stage SCLCPatients with a body weight of ≥ 30 kg:

        1,500 mg in combination with chemotherapy
        every 3 weeks (21 days) for 4 cycles, followed by 1,500 mg every 4 weeks as a single agent

        Patients with a body weight of < 30 kg:

        20 mg/kg in combination with chemotherapy
        every 3 weeks (21 days) for 4 cycles, followed by 10 mg/kg every 2 weeks as a single agent        		Until disease progression or until unacceptable toxicity
        BTCPatients with a body weight of ≥ 30 kg:

        1,500 mg in combination with chemotherapy
        every 3 weeks (21 days) up to 8 cycles followed by 1,500 mg every 4 weeks as a single agent

        Patients with a body weight of < 30 kg:

        20 mg/kg in combination with chemotherapy
        every 3 weeks (21 days) up to 8 cycles, followed by 20 mg/kg every 4 weeks as a single agent        		Until disease progression or until unacceptable toxicity
        uHCCPatients with a body weight of ≥ 30 kg:

        IMFINZI 1,500 mg following a single dose of tremelimumab-actlAdminister tremelimumab-actl prior to IMFINZI on the same day. When tremelimumab-actl is administered in combination with IMFINZI, refer to the Prescribing Information for tremelimumab-actl dosing information.300 mg at Day 1 of Cycle 1;

        Continue IMFINZI 1,500 mg as a single agent every 4 weeks

        Patients with a body weight of < 30 kg:

        IMFINZI 20 mg/kg following a single dose of tremelimumab-actl
        4 mg/kg at Day 1 of Cycle 1;

        Continue IMFINZI 20 mg/kg as a single agent every 4 weeks        		After Cycle 1 of combination therapy, administer IMFINZI as a single agent every 4 weeks until disease progression or unacceptable toxicity
        dMMR endometrial cancer
        Patients with a body weight of ≥ 30 kg:


        IMFINZI 1,120 mg in combination with carboplatin and paclitaxel
        every 3 weeks (21 days) for 6 cycles, followed by IMFINZI 1,500 mg every 4 weeks as a single agent


        Patients with a body weight of < 30 kg:


        IMFINZI 15 mg/kg in combination with carboplatin and paclitaxel
        every 3 weeks (21 days) for 6 cycles, followed by IMFINZI 20 mg/kg every 4 weeks as a single agent
        Until disease progression or unacceptable toxicity
        Neoadjuvant and Adjuvant Treatment of MIBC
        Patients with a body weight of ≥30 kg:


        Neoadjuvant: 1,500 mg in combination with gemcitabine and cisplatin
        every 3 weeks for 4 cycles prior to surgery


        Adjuvant: IMFINZI 1,500 mg as a single agent every 4 weeks for up to 8 cycles after surgery


        Patients with a body weight of < 30 kg:


        Neoadjuvant: 20 mg/kg in combination with gemcitabine and cisplatin
        every 3 weeks for 4 cycles prior to surgery


        Adjuvant: IMFINZI 20 mg/kg as a single agent every 4 weeks for up to 8 cycles after surgery
        Until disease progression that precludes definitive surgery, recurrence, or unacceptable toxicity or a maximum of 8 cycles after surgery
        Neoadjuvant and Adjuvant


        Treatment of Resectable


        GC/GEJC
        Patients with a body weight of ≥ 30


        kg:


        Neoadjuvant: IMFINZI 1,500 mg every 4 weeks with FLOT
        FLOT chemotherapy is administered on days 1 and 15 of each 4 week cycle
        [See Clinical Studies ]
        .
        for up to 2 cycles prior to surgery


        Adjuvant: IMFINZI 1,500 mg every 4 weeks with FLOT
        for up to 2 cycles, followed by IMFINZI 1,500 mg as a single agent every 4 weeks for up to 10 cycles


        Patients with a body weight of < 30 kg:


        Neoadjuvant: IMFINZI 20 mg/kg every 4 weeks with FLOT*± for up to 2 cycles prior to surgery


        Adjuvant: IMFINZI 20 mg/kg every 4 weeks with FLOT
        for up to 2 cycles, followed by IMFINZI 20 mg/kg as a single agent every 4 weeks for up to 10 cycles
        Neoadjuvant: Until disease progression that precludes definitive surgery or unacceptable toxicity

        IMFINZI in Combination with Tremelimumab-actl and Platinum-Based Chemotherapy

        The recommended dosage schedule and regimens for IMFINZI for the treatment of metastatic NSCLC are provided in Tables 2 and 3.

        Weigh patients prior to each infusion.

        Calculate the appropriate dose using Table 3 below based on the patient’s weight and tumor histology.

        Table 2. Recommended Dosage Schedule for Metastatic NSCLC
        Week
        continue IMFINZI until disease progression or intolerable toxicity.note the dosing interval change from every 3 weeks to every 4 weeks starting at cycle 5.
        0123456789101112131415161718192021222324
        Cycle:
        		12345678

        IMFINZI

        intravenous infusion over 60 minutes
        [see
        Dosage and Administration (2.4)
        ]
        .

        X

        X

        X

        X

        X

        X

        X

        X

        Tremelimumab-actl

        if patients receive fewer than 4 cycles of platinum-based chemotherapy, the remaining cycles of tremelimumab-actl (up to a total of 5) should be given after the platinum-based chemotherapy phase, in combination with IMFINZI, every 4 weeks.

        X

        X

        X

        X

        X

        Chemotherapy

        X

        X

        X

        X

        Xoptional pemetrexed therapy from week 12 until disease progression or intolerable toxicity for patients with non-squamous disease who received treatment with pemetrexed and carboplatin/cisplatin.

        X

        X

        X

        carboplatin & nab-paclitaxel

        OR

        carboplatin or cisplatin & pemetrexedcarboplatin & nab-paclitaxel

        OR

        carboplatin or cisplatin & gemcitabine
        Table 3. Recommended Regimen and Dosage for Metastatic NSCLC
        Tumor Histology
        Patient Weight
        IMFINZI Dosage
        Tremelimumab-actl DosageRefer to the Prescribing Information for dosing information.
        Platinum-based Chemotherapy Regimen

        Non-Squamous

        ≥ 30 kg

        1,500 mg

        75 mg

        ••

        < 30 kg

        20 mg/kg

        1 mg/kg

        Squamous

        ≥ 30 kg

        1,500 mg

        75 mg

        ••

        < 30 kg

        20 mg/kg

        1 mg/kg

        )
      • ∘Weight < 30 kg: administer IMFINZI 20 mg/kg every 3 weeks in combination with chemotherapy, and then 20 mg/kg every 4 weeks as a single agent. (
        2.2 Recommended Dosage

        The recommended dosages for IMFINZI as a single agent and IMFINZI in combination with other therapeutic agents are presented in Table 1. The recommended dosage schedule and regimens for IMFINZI for the treatment of metastatic NSCLC are provided in Tables 2 and 3

        [see Indications and Usage (1.1)].

        Administer IMFINZI as a 60 minute intravenous infusion after dilution

        [ see Dosage and Administration (2.3)].

        Table 1. Recommended Dosages of IMFINZI
        Indication
        Recommended IMFINZI Dosage
        Duration of Therapy
        Neoadjuvant and Adjuvant Treatment of Resectable NSCLC
        Patients with a body weight of ≥ 30 kg:


        Neoadjuvant: IMFINZI 1,500 mg in combination with chemotherapy
        Administer IMFINZI prior to chemotherapy on the same day. Refer to the Prescribing Information for the agent administered in combination with IMFINZI for recommended dosage information, as appropriate.
        every 3 weeks for up to 4 cycles prior to surgery


        Adjuvant: IMFINZI 1,500 mg as a single agent every 4 weeks for up to 12 cycles after surgery.


        Patients with a body weight of < 30 kg:

        Neoadjuvant: IMFINZI 20 mg/kg every 3 weeks in combination with chemotherapy
        for up to 4 cycles prior to surgery.

        Adjuvant: IMFINZI 20 mg/kg every 4 weeks for up to 12 cycles as a single agent after surgery.
        Until disease progression that precludes definitive surgery, recurrence, unacceptable toxicity, or a maximum of 12 cycles after surgery
        Unresectable Stage III NSCLCFollowing concurrent platinum-based chemotherapy and radiation therapy:

        Patients with a body weight of ≥ 30 kg:

        10 mg/kg every 2 weeks

        or

        1,500 mg every 4 weeks

        Patients with a body weight of < 30 kg:

        10 mg/kg every 2 weeks        		Until disease progression, unacceptable toxicity, or a maximum of 12 months
        Limited Stage SCLCFollowing concurrent platinum-based chemotherapy and radiation therapy:

        Patients with a body weight of ≥ 30 kg:

        1,500 mg every 4 weeks


        Patients with a body weight of < 30 kg:

        20 mg/kg every 4 weeks
        		Until disease progression, unacceptable toxicity, or a maximum of 24 months
        Extensive Stage SCLCPatients with a body weight of ≥ 30 kg:

        1,500 mg in combination with chemotherapy
        every 3 weeks (21 days) for 4 cycles, followed by 1,500 mg every 4 weeks as a single agent

        Patients with a body weight of < 30 kg:

        20 mg/kg in combination with chemotherapy
        every 3 weeks (21 days) for 4 cycles, followed by 10 mg/kg every 2 weeks as a single agent        		Until disease progression or until unacceptable toxicity
        BTCPatients with a body weight of ≥ 30 kg:

        1,500 mg in combination with chemotherapy
        every 3 weeks (21 days) up to 8 cycles followed by 1,500 mg every 4 weeks as a single agent

        Patients with a body weight of < 30 kg:

        20 mg/kg in combination with chemotherapy
        every 3 weeks (21 days) up to 8 cycles, followed by 20 mg/kg every 4 weeks as a single agent        		Until disease progression or until unacceptable toxicity
        uHCCPatients with a body weight of ≥ 30 kg:

        IMFINZI 1,500 mg following a single dose of tremelimumab-actlAdminister tremelimumab-actl prior to IMFINZI on the same day. When tremelimumab-actl is administered in combination with IMFINZI, refer to the Prescribing Information for tremelimumab-actl dosing information.300 mg at Day 1 of Cycle 1;

        Continue IMFINZI 1,500 mg as a single agent every 4 weeks

        Patients with a body weight of < 30 kg:

        IMFINZI 20 mg/kg following a single dose of tremelimumab-actl
        4 mg/kg at Day 1 of Cycle 1;

        Continue IMFINZI 20 mg/kg as a single agent every 4 weeks        		After Cycle 1 of combination therapy, administer IMFINZI as a single agent every 4 weeks until disease progression or unacceptable toxicity
        dMMR endometrial cancer
        Patients with a body weight of ≥ 30 kg:


        IMFINZI 1,120 mg in combination with carboplatin and paclitaxel
        every 3 weeks (21 days) for 6 cycles, followed by IMFINZI 1,500 mg every 4 weeks as a single agent


        Patients with a body weight of < 30 kg:


        IMFINZI 15 mg/kg in combination with carboplatin and paclitaxel
        every 3 weeks (21 days) for 6 cycles, followed by IMFINZI 20 mg/kg every 4 weeks as a single agent
        Until disease progression or unacceptable toxicity
        Neoadjuvant and Adjuvant Treatment of MIBC
        Patients with a body weight of ≥30 kg:


        Neoadjuvant: 1,500 mg in combination with gemcitabine and cisplatin
        every 3 weeks for 4 cycles prior to surgery


        Adjuvant: IMFINZI 1,500 mg as a single agent every 4 weeks for up to 8 cycles after surgery


        Patients with a body weight of < 30 kg:


        Neoadjuvant: 20 mg/kg in combination with gemcitabine and cisplatin
        every 3 weeks for 4 cycles prior to surgery


        Adjuvant: IMFINZI 20 mg/kg as a single agent every 4 weeks for up to 8 cycles after surgery
        Until disease progression that precludes definitive surgery, recurrence, or unacceptable toxicity or a maximum of 8 cycles after surgery
        Neoadjuvant and Adjuvant


        Treatment of Resectable


        GC/GEJC
        Patients with a body weight of ≥ 30


        kg:


        Neoadjuvant: IMFINZI 1,500 mg every 4 weeks with FLOT
        FLOT chemotherapy is administered on days 1 and 15 of each 4 week cycle
        [See Clinical Studies ]
        .
        for up to 2 cycles prior to surgery


        Adjuvant: IMFINZI 1,500 mg every 4 weeks with FLOT
        for up to 2 cycles, followed by IMFINZI 1,500 mg as a single agent every 4 weeks for up to 10 cycles


        Patients with a body weight of < 30 kg:


        Neoadjuvant: IMFINZI 20 mg/kg every 4 weeks with FLOT*± for up to 2 cycles prior to surgery


        Adjuvant: IMFINZI 20 mg/kg every 4 weeks with FLOT
        for up to 2 cycles, followed by IMFINZI 20 mg/kg as a single agent every 4 weeks for up to 10 cycles
        Neoadjuvant: Until disease progression that precludes definitive surgery or unacceptable toxicity

        IMFINZI in Combination with Tremelimumab-actl and Platinum-Based Chemotherapy

        The recommended dosage schedule and regimens for IMFINZI for the treatment of metastatic NSCLC are provided in Tables 2 and 3.

        Weigh patients prior to each infusion.

        Calculate the appropriate dose using Table 3 below based on the patient’s weight and tumor histology.

        Table 2. Recommended Dosage Schedule for Metastatic NSCLC
        Week
        continue IMFINZI until disease progression or intolerable toxicity.note the dosing interval change from every 3 weeks to every 4 weeks starting at cycle 5.
        0123456789101112131415161718192021222324
        Cycle:
        		12345678

        IMFINZI

        intravenous infusion over 60 minutes
        [see
        Dosage and Administration (2.4)
        ]
        .

        X

        X

        X

        X

        X

        X

        X

        X

        Tremelimumab-actl

        if patients receive fewer than 4 cycles of platinum-based chemotherapy, the remaining cycles of tremelimumab-actl (up to a total of 5) should be given after the platinum-based chemotherapy phase, in combination with IMFINZI, every 4 weeks.

        X

        X

        X

        X

        X

        Chemotherapy

        X

        X

        X

        X

        Xoptional pemetrexed therapy from week 12 until disease progression or intolerable toxicity for patients with non-squamous disease who received treatment with pemetrexed and carboplatin/cisplatin.

        X

        X

        X

        carboplatin & nab-paclitaxel

        OR

        carboplatin or cisplatin & pemetrexedcarboplatin & nab-paclitaxel

        OR

        carboplatin or cisplatin & gemcitabine
        Table 3. Recommended Regimen and Dosage for Metastatic NSCLC
        Tumor Histology
        Patient Weight
        IMFINZI Dosage
        Tremelimumab-actl DosageRefer to the Prescribing Information for dosing information.
        Platinum-based Chemotherapy Regimen

        Non-Squamous

        ≥ 30 kg

        1,500 mg

        75 mg

        ••

        < 30 kg

        20 mg/kg

        1 mg/kg

        Squamous

        ≥ 30 kg

        1,500 mg

        75 mg

        ••

        < 30 kg

        20 mg/kg

        1 mg/kg

        )
    • •uHCC:
      • ∘Weight ≥ 30 kg: IMFINZI 1,500 mg in combination with tremelimumab-actl 300 mg as a single dose at Cycle 1/Day 1, followed by IMFINZI as a single agent every 4 weeks. (
        2.2 Recommended Dosage

        The recommended dosages for IMFINZI as a single agent and IMFINZI in combination with other therapeutic agents are presented in Table 1. The recommended dosage schedule and regimens for IMFINZI for the treatment of metastatic NSCLC are provided in Tables 2 and 3

        [see Indications and Usage (1.1)].

        Administer IMFINZI as a 60 minute intravenous infusion after dilution

        [ see Dosage and Administration (2.3)].

        Table 1. Recommended Dosages of IMFINZI
        Indication
        Recommended IMFINZI Dosage
        Duration of Therapy
        Neoadjuvant and Adjuvant Treatment of Resectable NSCLC
        Patients with a body weight of ≥ 30 kg:


        Neoadjuvant: IMFINZI 1,500 mg in combination with chemotherapy
        Administer IMFINZI prior to chemotherapy on the same day. Refer to the Prescribing Information for the agent administered in combination with IMFINZI for recommended dosage information, as appropriate.
        every 3 weeks for up to 4 cycles prior to surgery


        Adjuvant: IMFINZI 1,500 mg as a single agent every 4 weeks for up to 12 cycles after surgery.


        Patients with a body weight of < 30 kg:

        Neoadjuvant: IMFINZI 20 mg/kg every 3 weeks in combination with chemotherapy
        for up to 4 cycles prior to surgery.

        Adjuvant: IMFINZI 20 mg/kg every 4 weeks for up to 12 cycles as a single agent after surgery.
        Until disease progression that precludes definitive surgery, recurrence, unacceptable toxicity, or a maximum of 12 cycles after surgery
        Unresectable Stage III NSCLCFollowing concurrent platinum-based chemotherapy and radiation therapy:

        Patients with a body weight of ≥ 30 kg:

        10 mg/kg every 2 weeks

        or

        1,500 mg every 4 weeks

        Patients with a body weight of < 30 kg:

        10 mg/kg every 2 weeks        		Until disease progression, unacceptable toxicity, or a maximum of 12 months
        Limited Stage SCLCFollowing concurrent platinum-based chemotherapy and radiation therapy:

        Patients with a body weight of ≥ 30 kg:

        1,500 mg every 4 weeks


        Patients with a body weight of < 30 kg:

        20 mg/kg every 4 weeks
        		Until disease progression, unacceptable toxicity, or a maximum of 24 months
        Extensive Stage SCLCPatients with a body weight of ≥ 30 kg:

        1,500 mg in combination with chemotherapy
        every 3 weeks (21 days) for 4 cycles, followed by 1,500 mg every 4 weeks as a single agent

        Patients with a body weight of < 30 kg:

        20 mg/kg in combination with chemotherapy
        every 3 weeks (21 days) for 4 cycles, followed by 10 mg/kg every 2 weeks as a single agent        		Until disease progression or until unacceptable toxicity
        BTCPatients with a body weight of ≥ 30 kg:

        1,500 mg in combination with chemotherapy
        every 3 weeks (21 days) up to 8 cycles followed by 1,500 mg every 4 weeks as a single agent

        Patients with a body weight of < 30 kg:

        20 mg/kg in combination with chemotherapy
        every 3 weeks (21 days) up to 8 cycles, followed by 20 mg/kg every 4 weeks as a single agent        		Until disease progression or until unacceptable toxicity
        uHCCPatients with a body weight of ≥ 30 kg:

        IMFINZI 1,500 mg following a single dose of tremelimumab-actlAdminister tremelimumab-actl prior to IMFINZI on the same day. When tremelimumab-actl is administered in combination with IMFINZI, refer to the Prescribing Information for tremelimumab-actl dosing information.300 mg at Day 1 of Cycle 1;

        Continue IMFINZI 1,500 mg as a single agent every 4 weeks

        Patients with a body weight of < 30 kg:

        IMFINZI 20 mg/kg following a single dose of tremelimumab-actl
        4 mg/kg at Day 1 of Cycle 1;

        Continue IMFINZI 20 mg/kg as a single agent every 4 weeks        		After Cycle 1 of combination therapy, administer IMFINZI as a single agent every 4 weeks until disease progression or unacceptable toxicity
        dMMR endometrial cancer
        Patients with a body weight of ≥ 30 kg:


        IMFINZI 1,120 mg in combination with carboplatin and paclitaxel
        every 3 weeks (21 days) for 6 cycles, followed by IMFINZI 1,500 mg every 4 weeks as a single agent


        Patients with a body weight of < 30 kg:


        IMFINZI 15 mg/kg in combination with carboplatin and paclitaxel
        every 3 weeks (21 days) for 6 cycles, followed by IMFINZI 20 mg/kg every 4 weeks as a single agent
        Until disease progression or unacceptable toxicity
        Neoadjuvant and Adjuvant Treatment of MIBC
        Patients with a body weight of ≥30 kg:


        Neoadjuvant: 1,500 mg in combination with gemcitabine and cisplatin
        every 3 weeks for 4 cycles prior to surgery


        Adjuvant: IMFINZI 1,500 mg as a single agent every 4 weeks for up to 8 cycles after surgery


        Patients with a body weight of < 30 kg:


        Neoadjuvant: 20 mg/kg in combination with gemcitabine and cisplatin
        every 3 weeks for 4 cycles prior to surgery


        Adjuvant: IMFINZI 20 mg/kg as a single agent every 4 weeks for up to 8 cycles after surgery
        Until disease progression that precludes definitive surgery, recurrence, or unacceptable toxicity or a maximum of 8 cycles after surgery
        Neoadjuvant and Adjuvant


        Treatment of Resectable


        GC/GEJC
        Patients with a body weight of ≥ 30


        kg:


        Neoadjuvant: IMFINZI 1,500 mg every 4 weeks with FLOT
        FLOT chemotherapy is administered on days 1 and 15 of each 4 week cycle
        [See Clinical Studies ]
        .
        for up to 2 cycles prior to surgery


        Adjuvant: IMFINZI 1,500 mg every 4 weeks with FLOT
        for up to 2 cycles, followed by IMFINZI 1,500 mg as a single agent every 4 weeks for up to 10 cycles


        Patients with a body weight of < 30 kg:


        Neoadjuvant: IMFINZI 20 mg/kg every 4 weeks with FLOT*± for up to 2 cycles prior to surgery


        Adjuvant: IMFINZI 20 mg/kg every 4 weeks with FLOT
        for up to 2 cycles, followed by IMFINZI 20 mg/kg as a single agent every 4 weeks for up to 10 cycles
        Neoadjuvant: Until disease progression that precludes definitive surgery or unacceptable toxicity

        IMFINZI in Combination with Tremelimumab-actl and Platinum-Based Chemotherapy

        The recommended dosage schedule and regimens for IMFINZI for the treatment of metastatic NSCLC are provided in Tables 2 and 3.

        Weigh patients prior to each infusion.

        Calculate the appropriate dose using Table 3 below based on the patient’s weight and tumor histology.

        Table 2. Recommended Dosage Schedule for Metastatic NSCLC
        Week
        continue IMFINZI until disease progression or intolerable toxicity.note the dosing interval change from every 3 weeks to every 4 weeks starting at cycle 5.
        0123456789101112131415161718192021222324
        Cycle:
        		12345678

        IMFINZI

        intravenous infusion over 60 minutes
        [see
        Dosage and Administration (2.4)
        ]
        .

        X

        X

        X

        X

        X

        X

        X

        X

        Tremelimumab-actl

        if patients receive fewer than 4 cycles of platinum-based chemotherapy, the remaining cycles of tremelimumab-actl (up to a total of 5) should be given after the platinum-based chemotherapy phase, in combination with IMFINZI, every 4 weeks.

        X

        X

        X

        X

        X

        Chemotherapy

        X

        X

        X

        X

        Xoptional pemetrexed therapy from week 12 until disease progression or intolerable toxicity for patients with non-squamous disease who received treatment with pemetrexed and carboplatin/cisplatin.

        X

        X

        X

        carboplatin & nab-paclitaxel

        OR

        carboplatin or cisplatin & pemetrexedcarboplatin & nab-paclitaxel

        OR

        carboplatin or cisplatin & gemcitabine
        Table 3. Recommended Regimen and Dosage for Metastatic NSCLC
        Tumor Histology
        Patient Weight
        IMFINZI Dosage
        Tremelimumab-actl DosageRefer to the Prescribing Information for dosing information.
        Platinum-based Chemotherapy Regimen

        Non-Squamous

        ≥ 30 kg

        1,500 mg

        75 mg

        ••

        < 30 kg

        20 mg/kg

        1 mg/kg

        Squamous

        ≥ 30 kg

        1,500 mg

        75 mg

        ••

        < 30 kg

        20 mg/kg

        1 mg/kg

        )
      • ∘Weight < 30 kg: IMFINZI 20 mg/kg in combination with tremelimumab-actl 4 mg/kg as a single dose at Cycle 1/Day 1, followed by IMFINZI as a single agent every 4 weeks. (
        2.2 Recommended Dosage

        The recommended dosages for IMFINZI as a single agent and IMFINZI in combination with other therapeutic agents are presented in Table 1. The recommended dosage schedule and regimens for IMFINZI for the treatment of metastatic NSCLC are provided in Tables 2 and 3

        [see Indications and Usage (1.1)].

        Administer IMFINZI as a 60 minute intravenous infusion after dilution

        [ see Dosage and Administration (2.3)].

        Table 1. Recommended Dosages of IMFINZI
        Indication
        Recommended IMFINZI Dosage
        Duration of Therapy
        Neoadjuvant and Adjuvant Treatment of Resectable NSCLC
        Patients with a body weight of ≥ 30 kg:


        Neoadjuvant: IMFINZI 1,500 mg in combination with chemotherapy
        Administer IMFINZI prior to chemotherapy on the same day. Refer to the Prescribing Information for the agent administered in combination with IMFINZI for recommended dosage information, as appropriate.
        every 3 weeks for up to 4 cycles prior to surgery


        Adjuvant: IMFINZI 1,500 mg as a single agent every 4 weeks for up to 12 cycles after surgery.


        Patients with a body weight of < 30 kg:

        Neoadjuvant: IMFINZI 20 mg/kg every 3 weeks in combination with chemotherapy
        for up to 4 cycles prior to surgery.

        Adjuvant: IMFINZI 20 mg/kg every 4 weeks for up to 12 cycles as a single agent after surgery.
        Until disease progression that precludes definitive surgery, recurrence, unacceptable toxicity, or a maximum of 12 cycles after surgery
        Unresectable Stage III NSCLCFollowing concurrent platinum-based chemotherapy and radiation therapy:

        Patients with a body weight of ≥ 30 kg:

        10 mg/kg every 2 weeks

        or

        1,500 mg every 4 weeks

        Patients with a body weight of < 30 kg:

        10 mg/kg every 2 weeks        		Until disease progression, unacceptable toxicity, or a maximum of 12 months
        Limited Stage SCLCFollowing concurrent platinum-based chemotherapy and radiation therapy:

        Patients with a body weight of ≥ 30 kg:

        1,500 mg every 4 weeks


        Patients with a body weight of < 30 kg:

        20 mg/kg every 4 weeks
        		Until disease progression, unacceptable toxicity, or a maximum of 24 months
        Extensive Stage SCLCPatients with a body weight of ≥ 30 kg:

        1,500 mg in combination with chemotherapy
        every 3 weeks (21 days) for 4 cycles, followed by 1,500 mg every 4 weeks as a single agent

        Patients with a body weight of < 30 kg:

        20 mg/kg in combination with chemotherapy
        every 3 weeks (21 days) for 4 cycles, followed by 10 mg/kg every 2 weeks as a single agent        		Until disease progression or until unacceptable toxicity
        BTCPatients with a body weight of ≥ 30 kg:

        1,500 mg in combination with chemotherapy
        every 3 weeks (21 days) up to 8 cycles followed by 1,500 mg every 4 weeks as a single agent

        Patients with a body weight of < 30 kg:

        20 mg/kg in combination with chemotherapy
        every 3 weeks (21 days) up to 8 cycles, followed by 20 mg/kg every 4 weeks as a single agent        		Until disease progression or until unacceptable toxicity
        uHCCPatients with a body weight of ≥ 30 kg:

        IMFINZI 1,500 mg following a single dose of tremelimumab-actlAdminister tremelimumab-actl prior to IMFINZI on the same day. When tremelimumab-actl is administered in combination with IMFINZI, refer to the Prescribing Information for tremelimumab-actl dosing information.300 mg at Day 1 of Cycle 1;

        Continue IMFINZI 1,500 mg as a single agent every 4 weeks

        Patients with a body weight of < 30 kg:

        IMFINZI 20 mg/kg following a single dose of tremelimumab-actl
        4 mg/kg at Day 1 of Cycle 1;

        Continue IMFINZI 20 mg/kg as a single agent every 4 weeks        		After Cycle 1 of combination therapy, administer IMFINZI as a single agent every 4 weeks until disease progression or unacceptable toxicity
        dMMR endometrial cancer
        Patients with a body weight of ≥ 30 kg:


        IMFINZI 1,120 mg in combination with carboplatin and paclitaxel
        every 3 weeks (21 days) for 6 cycles, followed by IMFINZI 1,500 mg every 4 weeks as a single agent


        Patients with a body weight of < 30 kg:


        IMFINZI 15 mg/kg in combination with carboplatin and paclitaxel
        every 3 weeks (21 days) for 6 cycles, followed by IMFINZI 20 mg/kg every 4 weeks as a single agent
        Until disease progression or unacceptable toxicity
        Neoadjuvant and Adjuvant Treatment of MIBC
        Patients with a body weight of ≥30 kg:


        Neoadjuvant: 1,500 mg in combination with gemcitabine and cisplatin
        every 3 weeks for 4 cycles prior to surgery


        Adjuvant: IMFINZI 1,500 mg as a single agent every 4 weeks for up to 8 cycles after surgery


        Patients with a body weight of < 30 kg:


        Neoadjuvant: 20 mg/kg in combination with gemcitabine and cisplatin
        every 3 weeks for 4 cycles prior to surgery


        Adjuvant: IMFINZI 20 mg/kg as a single agent every 4 weeks for up to 8 cycles after surgery
        Until disease progression that precludes definitive surgery, recurrence, or unacceptable toxicity or a maximum of 8 cycles after surgery
        Neoadjuvant and Adjuvant


        Treatment of Resectable


        GC/GEJC
        Patients with a body weight of ≥ 30


        kg:


        Neoadjuvant: IMFINZI 1,500 mg every 4 weeks with FLOT
        FLOT chemotherapy is administered on days 1 and 15 of each 4 week cycle
        [See Clinical Studies ]
        .
        for up to 2 cycles prior to surgery


        Adjuvant: IMFINZI 1,500 mg every 4 weeks with FLOT
        for up to 2 cycles, followed by IMFINZI 1,500 mg as a single agent every 4 weeks for up to 10 cycles


        Patients with a body weight of < 30 kg:


        Neoadjuvant: IMFINZI 20 mg/kg every 4 weeks with FLOT*± for up to 2 cycles prior to surgery


        Adjuvant: IMFINZI 20 mg/kg every 4 weeks with FLOT
        for up to 2 cycles, followed by IMFINZI 20 mg/kg as a single agent every 4 weeks for up to 10 cycles
        Neoadjuvant: Until disease progression that precludes definitive surgery or unacceptable toxicity

        IMFINZI in Combination with Tremelimumab-actl and Platinum-Based Chemotherapy

        The recommended dosage schedule and regimens for IMFINZI for the treatment of metastatic NSCLC are provided in Tables 2 and 3.

        Weigh patients prior to each infusion.

        Calculate the appropriate dose using Table 3 below based on the patient’s weight and tumor histology.

        Table 2. Recommended Dosage Schedule for Metastatic NSCLC
        Week
        continue IMFINZI until disease progression or intolerable toxicity.note the dosing interval change from every 3 weeks to every 4 weeks starting at cycle 5.
        0123456789101112131415161718192021222324
        Cycle:
        		12345678

        IMFINZI

        intravenous infusion over 60 minutes
        [see
        Dosage and Administration (2.4)
        ]
        .

        X

        X

        X

        X

        X

        X

        X

        X

        Tremelimumab-actl

        if patients receive fewer than 4 cycles of platinum-based chemotherapy, the remaining cycles of tremelimumab-actl (up to a total of 5) should be given after the platinum-based chemotherapy phase, in combination with IMFINZI, every 4 weeks.

        X

        X

        X

        X

        X

        Chemotherapy

        X

        X

        X

        X

        Xoptional pemetrexed therapy from week 12 until disease progression or intolerable toxicity for patients with non-squamous disease who received treatment with pemetrexed and carboplatin/cisplatin.

        X

        X

        X

        carboplatin & nab-paclitaxel

        OR

        carboplatin or cisplatin & pemetrexedcarboplatin & nab-paclitaxel

        OR

        carboplatin or cisplatin & gemcitabine
        Table 3. Recommended Regimen and Dosage for Metastatic NSCLC
        Tumor Histology
        Patient Weight
        IMFINZI Dosage
        Tremelimumab-actl DosageRefer to the Prescribing Information for dosing information.
        Platinum-based Chemotherapy Regimen

        Non-Squamous

        ≥ 30 kg

        1,500 mg

        75 mg

        ••

        < 30 kg

        20 mg/kg

        1 mg/kg

        Squamous

        ≥ 30 kg

        1,500 mg

        75 mg

        ••

        < 30 kg

        20 mg/kg

        1 mg/kg

        )
    • •dMMR endometrial cancer:
      • ∘Weight ≥ 30 kg: IMFINZI 1,120 mg in combination with carboplatin and paclitaxel every 3 weeks for 6 cycles, followed by IMFINZI 1,500 mg every 4 weeks as a single agent. (
        2.1 Patient Selection

        Advanced or Recurrent dMMR Endometrial Cancer

        Select patients for treatment based on the presence of dMMR in tumor specimens
        [see Clinical Studies (14.5)].

        Information on FDA-approved tests for the detection of dMMR status in endometrial cancer is available at
        https://www.fda.gov/companiondiagnostics
        .

        ,
        2.2 Recommended Dosage

        The recommended dosages for IMFINZI as a single agent and IMFINZI in combination with other therapeutic agents are presented in Table 1. The recommended dosage schedule and regimens for IMFINZI for the treatment of metastatic NSCLC are provided in Tables 2 and 3

        [see Indications and Usage (1.1)].

        Administer IMFINZI as a 60 minute intravenous infusion after dilution

        [ see Dosage and Administration (2.3)].

        Table 1. Recommended Dosages of IMFINZI
        Indication
        Recommended IMFINZI Dosage
        Duration of Therapy
        Neoadjuvant and Adjuvant Treatment of Resectable NSCLC
        Patients with a body weight of ≥ 30 kg:


        Neoadjuvant: IMFINZI 1,500 mg in combination with chemotherapy
        Administer IMFINZI prior to chemotherapy on the same day. Refer to the Prescribing Information for the agent administered in combination with IMFINZI for recommended dosage information, as appropriate.
        every 3 weeks for up to 4 cycles prior to surgery


        Adjuvant: IMFINZI 1,500 mg as a single agent every 4 weeks for up to 12 cycles after surgery.


        Patients with a body weight of < 30 kg:

        Neoadjuvant: IMFINZI 20 mg/kg every 3 weeks in combination with chemotherapy
        for up to 4 cycles prior to surgery.

        Adjuvant: IMFINZI 20 mg/kg every 4 weeks for up to 12 cycles as a single agent after surgery.
        Until disease progression that precludes definitive surgery, recurrence, unacceptable toxicity, or a maximum of 12 cycles after surgery
        Unresectable Stage III NSCLCFollowing concurrent platinum-based chemotherapy and radiation therapy:

        Patients with a body weight of ≥ 30 kg:

        10 mg/kg every 2 weeks

        or

        1,500 mg every 4 weeks

        Patients with a body weight of < 30 kg:

        10 mg/kg every 2 weeks        		Until disease progression, unacceptable toxicity, or a maximum of 12 months
        Limited Stage SCLCFollowing concurrent platinum-based chemotherapy and radiation therapy:

        Patients with a body weight of ≥ 30 kg:

        1,500 mg every 4 weeks


        Patients with a body weight of < 30 kg:

        20 mg/kg every 4 weeks
        		Until disease progression, unacceptable toxicity, or a maximum of 24 months
        Extensive Stage SCLCPatients with a body weight of ≥ 30 kg:

        1,500 mg in combination with chemotherapy
        every 3 weeks (21 days) for 4 cycles, followed by 1,500 mg every 4 weeks as a single agent

        Patients with a body weight of < 30 kg:

        20 mg/kg in combination with chemotherapy
        every 3 weeks (21 days) for 4 cycles, followed by 10 mg/kg every 2 weeks as a single agent        		Until disease progression or until unacceptable toxicity
        BTCPatients with a body weight of ≥ 30 kg:

        1,500 mg in combination with chemotherapy
        every 3 weeks (21 days) up to 8 cycles followed by 1,500 mg every 4 weeks as a single agent

        Patients with a body weight of < 30 kg:

        20 mg/kg in combination with chemotherapy
        every 3 weeks (21 days) up to 8 cycles, followed by 20 mg/kg every 4 weeks as a single agent        		Until disease progression or until unacceptable toxicity
        uHCCPatients with a body weight of ≥ 30 kg:

        IMFINZI 1,500 mg following a single dose of tremelimumab-actlAdminister tremelimumab-actl prior to IMFINZI on the same day. When tremelimumab-actl is administered in combination with IMFINZI, refer to the Prescribing Information for tremelimumab-actl dosing information.300 mg at Day 1 of Cycle 1;

        Continue IMFINZI 1,500 mg as a single agent every 4 weeks

        Patients with a body weight of < 30 kg:

        IMFINZI 20 mg/kg following a single dose of tremelimumab-actl
        4 mg/kg at Day 1 of Cycle 1;

        Continue IMFINZI 20 mg/kg as a single agent every 4 weeks        		After Cycle 1 of combination therapy, administer IMFINZI as a single agent every 4 weeks until disease progression or unacceptable toxicity
        dMMR endometrial cancer
        Patients with a body weight of ≥ 30 kg:


        IMFINZI 1,120 mg in combination with carboplatin and paclitaxel
        every 3 weeks (21 days) for 6 cycles, followed by IMFINZI 1,500 mg every 4 weeks as a single agent


        Patients with a body weight of < 30 kg:


        IMFINZI 15 mg/kg in combination with carboplatin and paclitaxel
        every 3 weeks (21 days) for 6 cycles, followed by IMFINZI 20 mg/kg every 4 weeks as a single agent
        Until disease progression or unacceptable toxicity
        Neoadjuvant and Adjuvant Treatment of MIBC
        Patients with a body weight of ≥30 kg:


        Neoadjuvant: 1,500 mg in combination with gemcitabine and cisplatin
        every 3 weeks for 4 cycles prior to surgery


        Adjuvant: IMFINZI 1,500 mg as a single agent every 4 weeks for up to 8 cycles after surgery


        Patients with a body weight of < 30 kg:


        Neoadjuvant: 20 mg/kg in combination with gemcitabine and cisplatin
        every 3 weeks for 4 cycles prior to surgery


        Adjuvant: IMFINZI 20 mg/kg as a single agent every 4 weeks for up to 8 cycles after surgery
        Until disease progression that precludes definitive surgery, recurrence, or unacceptable toxicity or a maximum of 8 cycles after surgery
        Neoadjuvant and Adjuvant


        Treatment of Resectable


        GC/GEJC
        Patients with a body weight of ≥ 30


        kg:


        Neoadjuvant: IMFINZI 1,500 mg every 4 weeks with FLOT
        FLOT chemotherapy is administered on days 1 and 15 of each 4 week cycle
        [See Clinical Studies ]
        .
        for up to 2 cycles prior to surgery


        Adjuvant: IMFINZI 1,500 mg every 4 weeks with FLOT
        for up to 2 cycles, followed by IMFINZI 1,500 mg as a single agent every 4 weeks for up to 10 cycles


        Patients with a body weight of < 30 kg:


        Neoadjuvant: IMFINZI 20 mg/kg every 4 weeks with FLOT*± for up to 2 cycles prior to surgery


        Adjuvant: IMFINZI 20 mg/kg every 4 weeks with FLOT
        for up to 2 cycles, followed by IMFINZI 20 mg/kg as a single agent every 4 weeks for up to 10 cycles
        Neoadjuvant: Until disease progression that precludes definitive surgery or unacceptable toxicity

        IMFINZI in Combination with Tremelimumab-actl and Platinum-Based Chemotherapy

        The recommended dosage schedule and regimens for IMFINZI for the treatment of metastatic NSCLC are provided in Tables 2 and 3.

        Weigh patients prior to each infusion.

        Calculate the appropriate dose using Table 3 below based on the patient’s weight and tumor histology.

        Table 2. Recommended Dosage Schedule for Metastatic NSCLC
        Week
        continue IMFINZI until disease progression or intolerable toxicity.note the dosing interval change from every 3 weeks to every 4 weeks starting at cycle 5.
        0123456789101112131415161718192021222324
        Cycle:
        		12345678

        IMFINZI

        intravenous infusion over 60 minutes
        [see
        Dosage and Administration (2.4)
        ]
        .

        X

        X

        X

        X

        X

        X

        X

        X

        Tremelimumab-actl

        if patients receive fewer than 4 cycles of platinum-based chemotherapy, the remaining cycles of tremelimumab-actl (up to a total of 5) should be given after the platinum-based chemotherapy phase, in combination with IMFINZI, every 4 weeks.

        X

        X

        X

        X

        X

        Chemotherapy

        X

        X

        X

        X

        Xoptional pemetrexed therapy from week 12 until disease progression or intolerable toxicity for patients with non-squamous disease who received treatment with pemetrexed and carboplatin/cisplatin.

        X

        X

        X

        carboplatin & nab-paclitaxel

        OR

        carboplatin or cisplatin & pemetrexedcarboplatin & nab-paclitaxel

        OR

        carboplatin or cisplatin & gemcitabine
        Table 3. Recommended Regimen and Dosage for Metastatic NSCLC
        Tumor Histology
        Patient Weight
        IMFINZI Dosage
        Tremelimumab-actl DosageRefer to the Prescribing Information for dosing information.
        Platinum-based Chemotherapy Regimen

        Non-Squamous

        ≥ 30 kg

        1,500 mg

        75 mg

        ••

        < 30 kg

        20 mg/kg

        1 mg/kg

        Squamous

        ≥ 30 kg

        1,500 mg

        75 mg

        ••

        < 30 kg

        20 mg/kg

        1 mg/kg

        )
      • ∘Weight < 30 kg: IMFINZI 15 mg/kg in combination with carboplatin and paclitaxel every 3 weeks for 6 cycles, followed by IMFINZI 20 mg/kg every 4 weeks as a single agent. (
        2.1 Patient Selection

        Advanced or Recurrent dMMR Endometrial Cancer

        Select patients for treatment based on the presence of dMMR in tumor specimens
        [see Clinical Studies (14.5)].

        Information on FDA-approved tests for the detection of dMMR status in endometrial cancer is available at
        https://www.fda.gov/companiondiagnostics
        .

        ,
        2.2 Recommended Dosage

        The recommended dosages for IMFINZI as a single agent and IMFINZI in combination with other therapeutic agents are presented in Table 1. The recommended dosage schedule and regimens for IMFINZI for the treatment of metastatic NSCLC are provided in Tables 2 and 3

        [see Indications and Usage (1.1)].

        Administer IMFINZI as a 60 minute intravenous infusion after dilution

        [ see Dosage and Administration (2.3)].

        Table 1. Recommended Dosages of IMFINZI
        Indication
        Recommended IMFINZI Dosage
        Duration of Therapy
        Neoadjuvant and Adjuvant Treatment of Resectable NSCLC
        Patients with a body weight of ≥ 30 kg:


        Neoadjuvant: IMFINZI 1,500 mg in combination with chemotherapy
        Administer IMFINZI prior to chemotherapy on the same day. Refer to the Prescribing Information for the agent administered in combination with IMFINZI for recommended dosage information, as appropriate.
        every 3 weeks for up to 4 cycles prior to surgery


        Adjuvant: IMFINZI 1,500 mg as a single agent every 4 weeks for up to 12 cycles after surgery.


        Patients with a body weight of < 30 kg:

        Neoadjuvant: IMFINZI 20 mg/kg every 3 weeks in combination with chemotherapy
        for up to 4 cycles prior to surgery.

        Adjuvant: IMFINZI 20 mg/kg every 4 weeks for up to 12 cycles as a single agent after surgery.
        Until disease progression that precludes definitive surgery, recurrence, unacceptable toxicity, or a maximum of 12 cycles after surgery
        Unresectable Stage III NSCLCFollowing concurrent platinum-based chemotherapy and radiation therapy:

        Patients with a body weight of ≥ 30 kg:

        10 mg/kg every 2 weeks

        or

        1,500 mg every 4 weeks

        Patients with a body weight of < 30 kg:

        10 mg/kg every 2 weeks        		Until disease progression, unacceptable toxicity, or a maximum of 12 months
        Limited Stage SCLCFollowing concurrent platinum-based chemotherapy and radiation therapy:

        Patients with a body weight of ≥ 30 kg:

        1,500 mg every 4 weeks


        Patients with a body weight of < 30 kg:

        20 mg/kg every 4 weeks
        		Until disease progression, unacceptable toxicity, or a maximum of 24 months
        Extensive Stage SCLCPatients with a body weight of ≥ 30 kg:

        1,500 mg in combination with chemotherapy
        every 3 weeks (21 days) for 4 cycles, followed by 1,500 mg every 4 weeks as a single agent

        Patients with a body weight of < 30 kg:

        20 mg/kg in combination with chemotherapy
        every 3 weeks (21 days) for 4 cycles, followed by 10 mg/kg every 2 weeks as a single agent        		Until disease progression or until unacceptable toxicity
        BTCPatients with a body weight of ≥ 30 kg:

        1,500 mg in combination with chemotherapy
        every 3 weeks (21 days) up to 8 cycles followed by 1,500 mg every 4 weeks as a single agent

        Patients with a body weight of < 30 kg:

        20 mg/kg in combination with chemotherapy
        every 3 weeks (21 days) up to 8 cycles, followed by 20 mg/kg every 4 weeks as a single agent        		Until disease progression or until unacceptable toxicity
        uHCCPatients with a body weight of ≥ 30 kg:

        IMFINZI 1,500 mg following a single dose of tremelimumab-actlAdminister tremelimumab-actl prior to IMFINZI on the same day. When tremelimumab-actl is administered in combination with IMFINZI, refer to the Prescribing Information for tremelimumab-actl dosing information.300 mg at Day 1 of Cycle 1;

        Continue IMFINZI 1,500 mg as a single agent every 4 weeks

        Patients with a body weight of < 30 kg:

        IMFINZI 20 mg/kg following a single dose of tremelimumab-actl
        4 mg/kg at Day 1 of Cycle 1;

        Continue IMFINZI 20 mg/kg as a single agent every 4 weeks        		After Cycle 1 of combination therapy, administer IMFINZI as a single agent every 4 weeks until disease progression or unacceptable toxicity
        dMMR endometrial cancer
        Patients with a body weight of ≥ 30 kg:


        IMFINZI 1,120 mg in combination with carboplatin and paclitaxel
        every 3 weeks (21 days) for 6 cycles, followed by IMFINZI 1,500 mg every 4 weeks as a single agent


        Patients with a body weight of < 30 kg:


        IMFINZI 15 mg/kg in combination with carboplatin and paclitaxel
        every 3 weeks (21 days) for 6 cycles, followed by IMFINZI 20 mg/kg every 4 weeks as a single agent
        Until disease progression or unacceptable toxicity
        Neoadjuvant and Adjuvant Treatment of MIBC
        Patients with a body weight of ≥30 kg:


        Neoadjuvant: 1,500 mg in combination with gemcitabine and cisplatin
        every 3 weeks for 4 cycles prior to surgery


        Adjuvant: IMFINZI 1,500 mg as a single agent every 4 weeks for up to 8 cycles after surgery


        Patients with a body weight of < 30 kg:


        Neoadjuvant: 20 mg/kg in combination with gemcitabine and cisplatin
        every 3 weeks for 4 cycles prior to surgery


        Adjuvant: IMFINZI 20 mg/kg as a single agent every 4 weeks for up to 8 cycles after surgery
        Until disease progression that precludes definitive surgery, recurrence, or unacceptable toxicity or a maximum of 8 cycles after surgery
        Neoadjuvant and Adjuvant


        Treatment of Resectable


        GC/GEJC
        Patients with a body weight of ≥ 30


        kg:


        Neoadjuvant: IMFINZI 1,500 mg every 4 weeks with FLOT
        FLOT chemotherapy is administered on days 1 and 15 of each 4 week cycle
        [See Clinical Studies ]
        .
        for up to 2 cycles prior to surgery


        Adjuvant: IMFINZI 1,500 mg every 4 weeks with FLOT
        for up to 2 cycles, followed by IMFINZI 1,500 mg as a single agent every 4 weeks for up to 10 cycles


        Patients with a body weight of < 30 kg:


        Neoadjuvant: IMFINZI 20 mg/kg every 4 weeks with FLOT*± for up to 2 cycles prior to surgery


        Adjuvant: IMFINZI 20 mg/kg every 4 weeks with FLOT
        for up to 2 cycles, followed by IMFINZI 20 mg/kg as a single agent every 4 weeks for up to 10 cycles
        Neoadjuvant: Until disease progression that precludes definitive surgery or unacceptable toxicity

        IMFINZI in Combination with Tremelimumab-actl and Platinum-Based Chemotherapy

        The recommended dosage schedule and regimens for IMFINZI for the treatment of metastatic NSCLC are provided in Tables 2 and 3.

        Weigh patients prior to each infusion.

        Calculate the appropriate dose using Table 3 below based on the patient’s weight and tumor histology.

        Table 2. Recommended Dosage Schedule for Metastatic NSCLC
        Week
        continue IMFINZI until disease progression or intolerable toxicity.note the dosing interval change from every 3 weeks to every 4 weeks starting at cycle 5.
        0123456789101112131415161718192021222324
        Cycle:
        		12345678

        IMFINZI

        intravenous infusion over 60 minutes
        [see
        Dosage and Administration (2.4)
        ]
        .

        X

        X

        X

        X

        X

        X

        X

        X

        Tremelimumab-actl

        if patients receive fewer than 4 cycles of platinum-based chemotherapy, the remaining cycles of tremelimumab-actl (up to a total of 5) should be given after the platinum-based chemotherapy phase, in combination with IMFINZI, every 4 weeks.

        X

        X

        X

        X

        X

        Chemotherapy

        X

        X

        X

        X

        Xoptional pemetrexed therapy from week 12 until disease progression or intolerable toxicity for patients with non-squamous disease who received treatment with pemetrexed and carboplatin/cisplatin.

        X

        X

        X

        carboplatin & nab-paclitaxel

        OR

        carboplatin or cisplatin & pemetrexedcarboplatin & nab-paclitaxel

        OR

        carboplatin or cisplatin & gemcitabine
        Table 3. Recommended Regimen and Dosage for Metastatic NSCLC
        Tumor Histology
        Patient Weight
        IMFINZI Dosage
        Tremelimumab-actl DosageRefer to the Prescribing Information for dosing information.
        Platinum-based Chemotherapy Regimen

        Non-Squamous

        ≥ 30 kg

        1,500 mg

        75 mg

        ••

        < 30 kg

        20 mg/kg

        1 mg/kg

        Squamous

        ≥ 30 kg

        1,500 mg

        75 mg

        ••

        < 30 kg

        20 mg/kg

        1 mg/kg

        )
    • •MIBC:
      • ∘Weight ≥ 30 kg:

    Neoadjuvant:
    IMFINZI 1,500 mg in combination with gemcitabine and cisplatin every 3 weeks for 4 cycles prior to surgery.

    Adjuvant:
    IMFINZI 1,500 mg every 4 weeks as a single agent for up to 8 cycles after surgery. (
    2.2 Recommended Dosage

    The recommended dosages for IMFINZI as a single agent and IMFINZI in combination with other therapeutic agents are presented in Table 1. The recommended dosage schedule and regimens for IMFINZI for the treatment of metastatic NSCLC are provided in Tables 2 and 3

    [see Indications and Usage (1.1)].

    Administer IMFINZI as a 60 minute intravenous infusion after dilution

    [ see Dosage and Administration (2.3)].

    Table 1. Recommended Dosages of IMFINZI
    Indication
    Recommended IMFINZI Dosage
    Duration of Therapy
    Neoadjuvant and Adjuvant Treatment of Resectable NSCLC
    Patients with a body weight of ≥ 30 kg:


    Neoadjuvant: IMFINZI 1,500 mg in combination with chemotherapy
    Administer IMFINZI prior to chemotherapy on the same day. Refer to the Prescribing Information for the agent administered in combination with IMFINZI for recommended dosage information, as appropriate.
    every 3 weeks for up to 4 cycles prior to surgery


    Adjuvant: IMFINZI 1,500 mg as a single agent every 4 weeks for up to 12 cycles after surgery.


    Patients with a body weight of < 30 kg:

    Neoadjuvant: IMFINZI 20 mg/kg every 3 weeks in combination with chemotherapy
    for up to 4 cycles prior to surgery.

    Adjuvant: IMFINZI 20 mg/kg every 4 weeks for up to 12 cycles as a single agent after surgery.
    Until disease progression that precludes definitive surgery, recurrence, unacceptable toxicity, or a maximum of 12 cycles after surgery
    Unresectable Stage III NSCLCFollowing concurrent platinum-based chemotherapy and radiation therapy:

    Patients with a body weight of ≥ 30 kg:

    10 mg/kg every 2 weeks

    or

    1,500 mg every 4 weeks

    Patients with a body weight of < 30 kg:

    10 mg/kg every 2 weeks    		Until disease progression, unacceptable toxicity, or a maximum of 12 months
    Limited Stage SCLCFollowing concurrent platinum-based chemotherapy and radiation therapy:

    Patients with a body weight of ≥ 30 kg:

    1,500 mg every 4 weeks


    Patients with a body weight of < 30 kg:

    20 mg/kg every 4 weeks
    		Until disease progression, unacceptable toxicity, or a maximum of 24 months
    Extensive Stage SCLCPatients with a body weight of ≥ 30 kg:

    1,500 mg in combination with chemotherapy
    every 3 weeks (21 days) for 4 cycles, followed by 1,500 mg every 4 weeks as a single agent

    Patients with a body weight of < 30 kg:

    20 mg/kg in combination with chemotherapy
    every 3 weeks (21 days) for 4 cycles, followed by 10 mg/kg every 2 weeks as a single agent    		Until disease progression or until unacceptable toxicity
    BTCPatients with a body weight of ≥ 30 kg:

    1,500 mg in combination with chemotherapy
    every 3 weeks (21 days) up to 8 cycles followed by 1,500 mg every 4 weeks as a single agent

    Patients with a body weight of < 30 kg:

    20 mg/kg in combination with chemotherapy
    every 3 weeks (21 days) up to 8 cycles, followed by 20 mg/kg every 4 weeks as a single agent    		Until disease progression or until unacceptable toxicity
    uHCCPatients with a body weight of ≥ 30 kg:

    IMFINZI 1,500 mg following a single dose of tremelimumab-actlAdminister tremelimumab-actl prior to IMFINZI on the same day. When tremelimumab-actl is administered in combination with IMFINZI, refer to the Prescribing Information for tremelimumab-actl dosing information.300 mg at Day 1 of Cycle 1;

    Continue IMFINZI 1,500 mg as a single agent every 4 weeks

    Patients with a body weight of < 30 kg:

    IMFINZI 20 mg/kg following a single dose of tremelimumab-actl
    4 mg/kg at Day 1 of Cycle 1;

    Continue IMFINZI 20 mg/kg as a single agent every 4 weeks    		After Cycle 1 of combination therapy, administer IMFINZI as a single agent every 4 weeks until disease progression or unacceptable toxicity
    dMMR endometrial cancer
    Patients with a body weight of ≥ 30 kg:


    IMFINZI 1,120 mg in combination with carboplatin and paclitaxel
    every 3 weeks (21 days) for 6 cycles, followed by IMFINZI 1,500 mg every 4 weeks as a single agent


    Patients with a body weight of < 30 kg:


    IMFINZI 15 mg/kg in combination with carboplatin and paclitaxel
    every 3 weeks (21 days) for 6 cycles, followed by IMFINZI 20 mg/kg every 4 weeks as a single agent
    Until disease progression or unacceptable toxicity
    Neoadjuvant and Adjuvant Treatment of MIBC
    Patients with a body weight of ≥30 kg:


    Neoadjuvant: 1,500 mg in combination with gemcitabine and cisplatin
    every 3 weeks for 4 cycles prior to surgery


    Adjuvant: IMFINZI 1,500 mg as a single agent every 4 weeks for up to 8 cycles after surgery


    Patients with a body weight of < 30 kg:


    Neoadjuvant: 20 mg/kg in combination with gemcitabine and cisplatin
    every 3 weeks for 4 cycles prior to surgery


    Adjuvant: IMFINZI 20 mg/kg as a single agent every 4 weeks for up to 8 cycles after surgery
    Until disease progression that precludes definitive surgery, recurrence, or unacceptable toxicity or a maximum of 8 cycles after surgery
    Neoadjuvant and Adjuvant


    Treatment of Resectable


    GC/GEJC
    Patients with a body weight of ≥ 30


    kg:


    Neoadjuvant: IMFINZI 1,500 mg every 4 weeks with FLOT
    FLOT chemotherapy is administered on days 1 and 15 of each 4 week cycle
    [See Clinical Studies ]
    .
    for up to 2 cycles prior to surgery


    Adjuvant: IMFINZI 1,500 mg every 4 weeks with FLOT
    for up to 2 cycles, followed by IMFINZI 1,500 mg as a single agent every 4 weeks for up to 10 cycles


    Patients with a body weight of < 30 kg:


    Neoadjuvant: IMFINZI 20 mg/kg every 4 weeks with FLOT*± for up to 2 cycles prior to surgery


    Adjuvant: IMFINZI 20 mg/kg every 4 weeks with FLOT
    for up to 2 cycles, followed by IMFINZI 20 mg/kg as a single agent every 4 weeks for up to 10 cycles
    Neoadjuvant: Until disease progression that precludes definitive surgery or unacceptable toxicity

    IMFINZI in Combination with Tremelimumab-actl and Platinum-Based Chemotherapy

    The recommended dosage schedule and regimens for IMFINZI for the treatment of metastatic NSCLC are provided in Tables 2 and 3.

    Weigh patients prior to each infusion.

    Calculate the appropriate dose using Table 3 below based on the patient’s weight and tumor histology.

    Table 2. Recommended Dosage Schedule for Metastatic NSCLC
    Week
    continue IMFINZI until disease progression or intolerable toxicity.note the dosing interval change from every 3 weeks to every 4 weeks starting at cycle 5.
    0123456789101112131415161718192021222324
    Cycle:
    		12345678

    IMFINZI

    intravenous infusion over 60 minutes
    [see
    Dosage and Administration (2.4)
    ]
    .

    X

    X

    X

    X

    X

    X

    X

    X

    Tremelimumab-actl

    if patients receive fewer than 4 cycles of platinum-based chemotherapy, the remaining cycles of tremelimumab-actl (up to a total of 5) should be given after the platinum-based chemotherapy phase, in combination with IMFINZI, every 4 weeks.

    X

    X

    X

    X

    X

    Chemotherapy

    X

    X

    X

    X

    Xoptional pemetrexed therapy from week 12 until disease progression or intolerable toxicity for patients with non-squamous disease who received treatment with pemetrexed and carboplatin/cisplatin.

    X

    X

    X

    carboplatin & nab-paclitaxel

    OR

    carboplatin or cisplatin & pemetrexedcarboplatin & nab-paclitaxel

    OR

    carboplatin or cisplatin & gemcitabine
    Table 3. Recommended Regimen and Dosage for Metastatic NSCLC
    Tumor Histology
    Patient Weight
    IMFINZI Dosage
    Tremelimumab-actl DosageRefer to the Prescribing Information for dosing information.
    Platinum-based Chemotherapy Regimen

    Non-Squamous

    ≥ 30 kg

    1,500 mg

    75 mg

    ••

    < 30 kg

    20 mg/kg

    1 mg/kg

    Squamous

    ≥ 30 kg

    1,500 mg

    75 mg

    ••

    < 30 kg

    20 mg/kg

    1 mg/kg

    )

    •  
      • ∘Weight < 30 kg:

    Neoadjuvant:
    IMFINZI 20 mg/kg in combination with gemcitabine and cisplatin every 3 weeks for 4 cycles prior to surgery.

    Adjuvant:
    IMFINZI 20 mg/kg every 4 weeks as a single agent for up to 8 cycles after surgery. (
    2.2 Recommended Dosage

    The recommended dosages for IMFINZI as a single agent and IMFINZI in combination with other therapeutic agents are presented in Table 1. The recommended dosage schedule and regimens for IMFINZI for the treatment of metastatic NSCLC are provided in Tables 2 and 3

    [see Indications and Usage (1.1)].

    Administer IMFINZI as a 60 minute intravenous infusion after dilution

    [ see Dosage and Administration (2.3)].

    Table 1. Recommended Dosages of IMFINZI
    Indication
    Recommended IMFINZI Dosage
    Duration of Therapy
    Neoadjuvant and Adjuvant Treatment of Resectable NSCLC
    Patients with a body weight of ≥ 30 kg:


    Neoadjuvant: IMFINZI 1,500 mg in combination with chemotherapy
    Administer IMFINZI prior to chemotherapy on the same day. Refer to the Prescribing Information for the agent administered in combination with IMFINZI for recommended dosage information, as appropriate.
    every 3 weeks for up to 4 cycles prior to surgery


    Adjuvant: IMFINZI 1,500 mg as a single agent every 4 weeks for up to 12 cycles after surgery.


    Patients with a body weight of < 30 kg:

    Neoadjuvant: IMFINZI 20 mg/kg every 3 weeks in combination with chemotherapy
    for up to 4 cycles prior to surgery.

    Adjuvant: IMFINZI 20 mg/kg every 4 weeks for up to 12 cycles as a single agent after surgery.
    Until disease progression that precludes definitive surgery, recurrence, unacceptable toxicity, or a maximum of 12 cycles after surgery
    Unresectable Stage III NSCLCFollowing concurrent platinum-based chemotherapy and radiation therapy:

    Patients with a body weight of ≥ 30 kg:

    10 mg/kg every 2 weeks

    or

    1,500 mg every 4 weeks

    Patients with a body weight of < 30 kg:

    10 mg/kg every 2 weeks    		Until disease progression, unacceptable toxicity, or a maximum of 12 months
    Limited Stage SCLCFollowing concurrent platinum-based chemotherapy and radiation therapy:

    Patients with a body weight of ≥ 30 kg:

    1,500 mg every 4 weeks


    Patients with a body weight of < 30 kg:

    20 mg/kg every 4 weeks
    		Until disease progression, unacceptable toxicity, or a maximum of 24 months
    Extensive Stage SCLCPatients with a body weight of ≥ 30 kg:

    1,500 mg in combination with chemotherapy
    every 3 weeks (21 days) for 4 cycles, followed by 1,500 mg every 4 weeks as a single agent

    Patients with a body weight of < 30 kg:

    20 mg/kg in combination with chemotherapy
    every 3 weeks (21 days) for 4 cycles, followed by 10 mg/kg every 2 weeks as a single agent    		Until disease progression or until unacceptable toxicity
    BTCPatients with a body weight of ≥ 30 kg:

    1,500 mg in combination with chemotherapy
    every 3 weeks (21 days) up to 8 cycles followed by 1,500 mg every 4 weeks as a single agent

    Patients with a body weight of < 30 kg:

    20 mg/kg in combination with chemotherapy
    every 3 weeks (21 days) up to 8 cycles, followed by 20 mg/kg every 4 weeks as a single agent    		Until disease progression or until unacceptable toxicity
    uHCCPatients with a body weight of ≥ 30 kg:

    IMFINZI 1,500 mg following a single dose of tremelimumab-actlAdminister tremelimumab-actl prior to IMFINZI on the same day. When tremelimumab-actl is administered in combination with IMFINZI, refer to the Prescribing Information for tremelimumab-actl dosing information.300 mg at Day 1 of Cycle 1;

    Continue IMFINZI 1,500 mg as a single agent every 4 weeks

    Patients with a body weight of < 30 kg:

    IMFINZI 20 mg/kg following a single dose of tremelimumab-actl
    4 mg/kg at Day 1 of Cycle 1;

    Continue IMFINZI 20 mg/kg as a single agent every 4 weeks    		After Cycle 1 of combination therapy, administer IMFINZI as a single agent every 4 weeks until disease progression or unacceptable toxicity
    dMMR endometrial cancer
    Patients with a body weight of ≥ 30 kg:


    IMFINZI 1,120 mg in combination with carboplatin and paclitaxel
    every 3 weeks (21 days) for 6 cycles, followed by IMFINZI 1,500 mg every 4 weeks as a single agent


    Patients with a body weight of < 30 kg:


    IMFINZI 15 mg/kg in combination with carboplatin and paclitaxel
    every 3 weeks (21 days) for 6 cycles, followed by IMFINZI 20 mg/kg every 4 weeks as a single agent
    Until disease progression or unacceptable toxicity
    Neoadjuvant and Adjuvant Treatment of MIBC
    Patients with a body weight of ≥30 kg:


    Neoadjuvant: 1,500 mg in combination with gemcitabine and cisplatin
    every 3 weeks for 4 cycles prior to surgery


    Adjuvant: IMFINZI 1,500 mg as a single agent every 4 weeks for up to 8 cycles after surgery


    Patients with a body weight of < 30 kg:


    Neoadjuvant: 20 mg/kg in combination with gemcitabine and cisplatin
    every 3 weeks for 4 cycles prior to surgery


    Adjuvant: IMFINZI 20 mg/kg as a single agent every 4 weeks for up to 8 cycles after surgery
    Until disease progression that precludes definitive surgery, recurrence, or unacceptable toxicity or a maximum of 8 cycles after surgery
    Neoadjuvant and Adjuvant


    Treatment of Resectable


    GC/GEJC
    Patients with a body weight of ≥ 30


    kg:


    Neoadjuvant: IMFINZI 1,500 mg every 4 weeks with FLOT
    FLOT chemotherapy is administered on days 1 and 15 of each 4 week cycle
    [See Clinical Studies ]
    .
    for up to 2 cycles prior to surgery


    Adjuvant: IMFINZI 1,500 mg every 4 weeks with FLOT
    for up to 2 cycles, followed by IMFINZI 1,500 mg as a single agent every 4 weeks for up to 10 cycles


    Patients with a body weight of < 30 kg:


    Neoadjuvant: IMFINZI 20 mg/kg every 4 weeks with FLOT*± for up to 2 cycles prior to surgery


    Adjuvant: IMFINZI 20 mg/kg every 4 weeks with FLOT
    for up to 2 cycles, followed by IMFINZI 20 mg/kg as a single agent every 4 weeks for up to 10 cycles
    Neoadjuvant: Until disease progression that precludes definitive surgery or unacceptable toxicity

    IMFINZI in Combination with Tremelimumab-actl and Platinum-Based Chemotherapy

    The recommended dosage schedule and regimens for IMFINZI for the treatment of metastatic NSCLC are provided in Tables 2 and 3.

    Weigh patients prior to each infusion.

    Calculate the appropriate dose using Table 3 below based on the patient’s weight and tumor histology.

    Table 2. Recommended Dosage Schedule for Metastatic NSCLC
    Week
    continue IMFINZI until disease progression or intolerable toxicity.note the dosing interval change from every 3 weeks to every 4 weeks starting at cycle 5.
    0123456789101112131415161718192021222324
    Cycle:
    		12345678

    IMFINZI

    intravenous infusion over 60 minutes
    [see
    Dosage and Administration (2.4)
    ]
    .

    X

    X

    X

    X

    X

    X

    X

    X

    Tremelimumab-actl

    if patients receive fewer than 4 cycles of platinum-based chemotherapy, the remaining cycles of tremelimumab-actl (up to a total of 5) should be given after the platinum-based chemotherapy phase, in combination with IMFINZI, every 4 weeks.

    X

    X

    X

    X

    X

    Chemotherapy

    X

    X

    X

    X

    Xoptional pemetrexed therapy from week 12 until disease progression or intolerable toxicity for patients with non-squamous disease who received treatment with pemetrexed and carboplatin/cisplatin.

    X

    X

    X

    carboplatin & nab-paclitaxel

    OR

    carboplatin or cisplatin & pemetrexedcarboplatin & nab-paclitaxel

    OR

    carboplatin or cisplatin & gemcitabine
    Table 3. Recommended Regimen and Dosage for Metastatic NSCLC
    Tumor Histology
    Patient Weight
    IMFINZI Dosage
    Tremelimumab-actl DosageRefer to the Prescribing Information for dosing information.
    Platinum-based Chemotherapy Regimen

    Non-Squamous

    ≥ 30 kg

    1,500 mg

    75 mg

    ••

    < 30 kg

    20 mg/kg

    1 mg/kg

    Squamous

    ≥ 30 kg

    1,500 mg

    75 mg

    ••

    < 30 kg

    20 mg/kg

    1 mg/kg

    )

    • •See full Prescribing Information for preparation and administration instructions and dosage modifications for adverse reactions.

    Injection: 120 mg/2.4 mL (50 mg/mL) and 500 mg/10 mL (50 mg/mL) clear to opalescent, colorless to slightly yellow solution in a single-dose vial.

    Lactation: Advise not to breastfeed. (

    8.2 Lactation

    Risk Summary

    There are no data on the presence of durvalumab in human milk, its effects on the breastfed child, or the effects on milk production. Maternal IgG is known to be present in human milk. The effects of local gastrointestinal exposure and limited systemic exposure in the breastfed child to IMFINZI are unknown. Durvalumab was present in the milk of lactating cynomolgus monkeys and was associated with premature neonatal death

    (see Data).

    Because of the potential for adverse reactions in a breastfed child, advise women not to breastfeed during treatment with IMFINZI and for 3 months after the last dose. Refer to the Prescribing Information for the agents administered in combination with IMFINZI for recommended duration to not breastfeed, as appropriate.

    Data

    In lactating cynomolgus monkeys, durvalumab was present in breast milk at about 0.15% of maternal serum concentrations after administration of durvalumab from the confirmation of pregnancy through delivery at exposure levels approximately 6 to 20 times higher than those observed at the recommended clinical dose of 10 mg/kg (based on AUC). Administration of durvalumab resulted in premature neonatal death

    .

    )

    None.

    We receive information directly from the FDA and PrescriberPoint is updated as frequently as changes are made available
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