What is mechanism of action?

mechanism of action is Cytochrome P450 3A Inducers [MoA] or Type II RAF Kinase Inhibitors [MoA]

Ojemda

(Tovorafenib)

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Dosage & Administration

* Confirm the presence of

BRAF

fusion or rearrangement, or

BRAF V600

mutation prior to initiation of treatment with OJEMDA. (

2.1 Patient Selection

Select patients for treatment with OJEMDA based on the presence of

BRAF

fusion or rearrangement, or

BRAF V600

mutation in tumor specimens

[see Clinical Studies (14)].

Information on FDA-approved tests for the detection of

BRAF

fusions,

BRAF

rearrangements, and

BRAF V600

mutations is available at

http://www.fda.gov/companiondiagnostics

)
* Recommended dosage of OJEMDA is based on body surface area (

see

Table 1 Recommended OJEMDA Tablets Dosage Based on Body Surface Area
Body Surface Area (m²)	Recommended Dosage
0.30-0.89	Administer OJEMDA oral suspension once weekly (see Table 2)
0.90-1.12	400 mg once weekly
1.13-1.39	500 mg once weekly
≥ 1.40	600 mg once weekly

and

Table 2 Recommended Dosage for OJEMDA for Oral Suspension Based on Body Surface Area
Body Surface Area (m²)	Dose Volume (mL)OJEMDA for oral suspension has a concentration of 25 mg/mL. Each bottle of OJEMDA for oral suspension delivers 300 mg/12 mL.	Dosage
0.30-0.35	5	125 mg once weekly
0.36-0.42	6	150 mg once weekly
0.43-0.48	7	175 mg once weekly
0.49-0.54	8	200 mg once weekly
0.55-0.63	9	225 mg once weekly
0.64-0.77	11	275 mg once weekly
0.78-0.83	12	300 mg once weekly
0.84-0.89	14	350 mg once weekly
0.90-1.05	15	375 mg once weekly
1.06-1.25	18	450 mg once weekly
1.26-1.39	21	525 mg once weekly
≥1.40	24	600 mg once weekly

). (

2.3 Recommended Dosage

The recommended dosage of OJEMDA based on body surface area (BSA) is 380 mg/m²orally once weekly (the maximum recommended dosage is 600 mg orally once weekly) with or without food

[see Administration (2.4)and Clinical Pharmacology (12.3)]

until disease progression or intolerable toxicity. OJEMDA may be administered as an immediate release tablet (see Table 1) or as an oral suspension (see Table 2). A recommended dosage for patients with BSA less than 0.3 m²has not been established.

Table 1 Recommended OJEMDA Tablets Dosage Based on Body Surface Area
Body Surface Area (m²)	Recommended Dosage
0.30-0.89	Administer OJEMDA oral suspension once weekly (see Table 2)
0.90-1.12	400 mg once weekly
1.13-1.39	500 mg once weekly
≥ 1.40	600 mg once weekly

Table 2 Recommended Dosage for OJEMDA for Oral Suspension Based on Body Surface Area
Body Surface Area (m²)	Dose Volume (mL)OJEMDA for oral suspension has a concentration of 25 mg/mL. Each bottle of OJEMDA for oral suspension delivers 300 mg/12 mL.	Dosage
0.30-0.35	5	125 mg once weekly
0.36-0.42	6	150 mg once weekly
0.43-0.48	7	175 mg once weekly
0.49-0.54	8	200 mg once weekly
0.55-0.63	9	225 mg once weekly
0.64-0.77	11	275 mg once weekly
0.78-0.83	12	300 mg once weekly
0.84-0.89	14	350 mg once weekly
0.90-1.05	15	375 mg once weekly
1.06-1.25	18	450 mg once weekly
1.26-1.39	21	525 mg once weekly
≥1.40	24	600 mg once weekly

Continue once weekly dosing until disease progression or intolerable toxicity.

)
* Administer OJEMDA orally, once weekly, with or without food. (

2.3 Recommended Dosage

The recommended dosage of OJEMDA based on body surface area (BSA) is 380 mg/m²orally once weekly (the maximum recommended dosage is 600 mg orally once weekly) with or without food

[see Administration (2.4)and Clinical Pharmacology (12.3)]

Table 1 Recommended OJEMDA Tablets Dosage Based on Body Surface Area
Body Surface Area (m²)	Recommended Dosage
0.30-0.89	Administer OJEMDA oral suspension once weekly (see Table 2)
0.90-1.12	400 mg once weekly
1.13-1.39	500 mg once weekly
≥ 1.40	600 mg once weekly

Table 2 Recommended Dosage for OJEMDA for Oral Suspension Based on Body Surface Area
Body Surface Area (m²)	Dose Volume (mL)OJEMDA for oral suspension has a concentration of 25 mg/mL. Each bottle of OJEMDA for oral suspension delivers 300 mg/12 mL.	Dosage
0.30-0.35	5	125 mg once weekly
0.36-0.42	6	150 mg once weekly
0.43-0.48	7	175 mg once weekly
0.49-0.54	8	200 mg once weekly
0.55-0.63	9	225 mg once weekly
0.64-0.77	11	275 mg once weekly
0.78-0.83	12	300 mg once weekly
0.84-0.89	14	350 mg once weekly
0.90-1.05	15	375 mg once weekly
1.06-1.25	18	450 mg once weekly
1.26-1.39	21	525 mg once weekly
≥1.40	24	600 mg once weekly

Continue once weekly dosing until disease progression or intolerable toxicity.

2.4 Administration

* Take OJEMDA at a regularly scheduled time once weekly.
* OJEMDA may be taken with or without food

[see Clinical Pharmacology (12.3)].

If a dose is missed by:

* 3 days or less, take the missed dose as soon as possible, and take the next dose on its regularly scheduled day.
* more than 3 days, skip the missed dose and take the next dose on its regularly scheduled day.

If vomiting occurs immediately after taking a dose, repeat that dose.

OJEMDA tablets

* Swallow tablets whole with water.
* Do not chew, cut, or crush.

OJEMDA for oral suspension

* Prior to first time use of OJEMDA for oral suspension, ensure that caregivers (and if appropriate, patients) read and understand the "Instructions for Use" before preparing, measuring, and administering OJEMDA.

Preparation and Administration

* Reconstitute the powder in each supplied bottle with exactly 14 mL of room temperature water to form the OJEMDA for oral suspension. After reconstitution each mL contains 25 mg of tovorafenib. Product foaming after reconstitution reduces the deliverable volume.
* Each bottle delivers 300 mg of tovorafenib in 12 mL. For doses greater than 300 mg, reconstitute two bottles to achieve the dose. Split the dose as equally as possible between the two bottles (e.g., 6 mL and 7 mL for a 325 mg dose). Prepare the first bottle and administer dose prior to preparing the second bottle.
* Administer OJEMDA for oral suspension using the supplied oral dosing syringe or feeding tube (minimum 12 French) immediately after preparation.
* If the OJEMDA for oral suspension is not administered within 15 minutes after preparation, instruct the patient to discard it.

).
*

Tablets

: Swallow tablets whole with water. Do not chew, cut, or crush. (

2.4 Administration

* Take OJEMDA at a regularly scheduled time once weekly.
* OJEMDA may be taken with or without food

[see Clinical Pharmacology (12.3)].

If a dose is missed by:

If vomiting occurs immediately after taking a dose, repeat that dose.

OJEMDA tablets

* Swallow tablets whole with water.
* Do not chew, cut, or crush.

OJEMDA for oral suspension

Preparation and Administration

)
*

For Oral Suspension

: See full prescribing information for preparation and administration instructions. (

2.4 Administration

* Take OJEMDA at a regularly scheduled time once weekly.
* OJEMDA may be taken with or without food

[see Clinical Pharmacology (12.3)].

If a dose is missed by:

If vomiting occurs immediately after taking a dose, repeat that dose.

OJEMDA tablets

* Swallow tablets whole with water.
* Do not chew, cut, or crush.

OJEMDA for oral suspension

Preparation and Administration

)

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Ojemda Prescribing Information

Dosage and Administration (

2.1 Patient Selection

Select patients for treatment with OJEMDA based on the presence of

BRAF

fusion or rearrangement, or

BRAF V600

mutation in tumor specimens

[see Clinical Studies (14)].

Information on FDA-approved tests for the detection of

BRAF

fusions,

BRAF

rearrangements, and

BRAF V600

mutations is available at

http://www.fda.gov/companiondiagnostics

)

08/2025

Warnings and Precautions (

5.4 Effect on Growth

OJEMDA can cause reductions in growth velocity. In FIREFLY-1

[see Adverse Reactions (6.1)]

, treatment-emergent adverse effects on growth were reported in 46% of 133 patients 18 years of age or younger; 35% were Grade 3 or higher. Reduction in growth velocity resulted in dose interruption in 5% of patients, dose reduction in 2.3% of patients, and permanent discontinuation in 3% of patients. The median change from baseline in height percentile was -14 (z-score change -0.6) for evaluable patients on study for 12 months (N=107) and -20 (z-score change -0.9) for evaluable patients on study for 18 months (N=95).

Growth velocity improved after interruption of treatment with OJEMDA. Among 81 evaluable patients, the median annualized growth velocity ranged from 0.86 to 1.8 cm/year during the 2-year treatment period. Of those, 17 patients had height measurements recorded at least 90 days off-treatment and had a 4.2 cm/year median annualized growth velocity. Routinely monitor patient growth during treatment with OJEMDA

[see Adverse Reactions (6), Use in Specific Populations (8.4)].

)

08/2025

OJEMDA is indicated for the treatment of patients 6 months of age and older with relapsed or refractory pediatric low-grade glioma (LGG) harboring a

BRAF

fusion or rearrangement, or

BRAF V600

mutation.

This indication is approved under accelerated approval based on response rate and duration of response

[see

14 CLINICAL STUDIES

The efficacy of OJEMDA was evaluated in a multicenter, open-label, single-arm clinical trial (FIREFLY-1; NCT04775485). Eligible patients (N=76) were required to have a relapsed or refractory pediatric low-grade glioma (LGG) harboring an activating

BRAF

alteration based on local laboratory testing. Patients were also required to have at least one measurable lesion as defined by RANO 2010 criteria. All patients had received at least one line of prior systemic therapy and had documented evidence of radiographic progression. Patients with tumors harboring additional activating molecular alteration(s) (e.g., IDH1/2 mutations, FGFR mutations, etc.) or patients with known or suspected diagnosis of neurofibromatosis type 1 (NF1) were excluded.

Patients received OJEMDA approximately 420 mg/m²orally once weekly (range: 290 to 476 mg/m², 0.76-1.25 times the approved recommended dosage) according to body surface area with a maximum dose of 600 mg until disease progression or unacceptable toxicity. Although the OJEMDA dosages administered in FIREFLY-1 were between 290 mg/m²to 476 mg/m², the recommended OJEMDA dosage is 380 mg/m²orally once weekly because this dosage was determined to be safe and effective for the treatment of patients 6 months of age and older with relapsed or refractory pediatric LGG harboring a

BRAF

fusion or rearrangement, or

BRAF V600

mutation

[see Dosage and Administration (2.3)].

Tumor assessments were performed every 12 weeks.

The major efficacy outcome measure was overall response rate (ORR), defined as the proportion of patients with complete response (CR), partial response (PR), or minor response (MR) by blinded independent central review based on RAPNO-LGG (Response Assessment in Pediatric Neuro-Oncology) criteria. Additional efficacy outcome measures were duration of response, time to response, and ORR by independent review based on RANO-LGG (2011) criteria.

The efficacy population included 76 patients who had measurable disease at baseline and who received OJEMDA. The median age was 8.5 years (range 2 to 21 years); 53% were male; 61% White, 7% Asian, 2.6% Black or African American, 3.9% multiple races, 8% other race, 18% where race was not reported; 3.9% were Hispanic or Latino, and 93% had Karnofsky/Lansky performance status of 80 to 100. Patients received a median of 3 prior systemic regimens (range: 1 to 9). Forty-five patients (59%) received prior treatment with a MAP kinase pathway inhibitor. The most common tumor locations were the optic pathway (51%), deep midline structures (12%), brain stem (8%), cerebellum (7%), and cerebral hemisphere (5%). Fifty-six patients (74%) had a

KIAA1549:BRAF

fusion, twelve patients (16%) had a

V600E

mutation, and eight patients (11%) had a

BRAF

alteration classified as "other" including

BRAF

duplication or

BRAF

rearrangement. Efficacy results are shown in Table 10.

Table 10 Efficacy Results in FIREFLY-1
Efficacy Parameter	OJEMDAEfficacy Results Based on RAPNO-LGG criteria in FIREFLY-1 N=76At least one measurable lesion at baseline based on RAPNO-LGG criteria.
Abbreviations: LGG = low-grade glioma; RAPNO = Response Assessment in Pediatric Neuro-Oncology; CI = confidence interval.
Overall Response Rate
ORR (95% CI)Based on Clopper-Pearson exact confidence interval.	53% (41, 64)
Partial Response (PR), n (%)	29 (38)
Minor Response (MR), n (%)	11 (14)
Duration of Response (DoR)	N=40
Median (95% CI)Based on Kaplan-Meier estimate., Months	18 (12.0, 22.8)
% with observed DoR ≥ 12 months	65%
% with observed DoR ≥ 18 months	50%

Among responders, the median time to response was 5.4 months (range 1.6, 17.5). In exploratory analyses of

BRAF

alteration status, the ORR was 53% among patients with

BRAF

fusion or rearrangement (n=64), and 50% among patients with

BRAF V600E

mutation (n=12), respectively. In exploratory analyses of prior therapies, the ORR was 51% among patients who had received prior MAPK-targeted therapy (n=45), and 55% among patients who had not received prior MAPK-targeted therapy (n=31).

Based on RANO-LGG (2011) criteria (n=76), the ORR was 54% [95% CI: (42, 65)], including 23 patients with PR and 18 patients with MR.

Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

Confirm the presence of
BRAF
fusion or rearrangement, or
BRAF V600
mutation prior to initiation of treatment with OJEMDA. (
2.1 Patient Selection
Select patients for treatment with OJEMDA based on the presence of
BRAF
fusion or rearrangement, or
BRAF V600
mutation in tumor specimens
[see Clinical Studies (14)].
Information on FDA-approved tests for the detection of
BRAF
fusions,
BRAF
rearrangements, and
BRAF V600
mutations is available at
http://www.fda.gov/companiondiagnostics
.
)

Recommended dosage of OJEMDA is based on body surface area (

see

Table 1 Recommended OJEMDA Tablets Dosage Based on Body Surface Area
Body Surface Area (m²)	Recommended Dosage
0.30-0.89	Administer OJEMDA oral suspension once weekly (see Table 2)
0.90-1.12	400 mg once weekly
1.13-1.39	500 mg once weekly
≥ 1.40	600 mg once weekly

and

Table 2 Recommended Dosage for OJEMDA for Oral Suspension Based on Body Surface Area
Body Surface Area (m²)	Dose Volume (mL)OJEMDA for oral suspension has a concentration of 25 mg/mL. Each bottle of OJEMDA for oral suspension delivers 300 mg/12 mL.	Dosage
0.30-0.35	5	125 mg once weekly
0.36-0.42	6	150 mg once weekly
0.43-0.48	7	175 mg once weekly
0.49-0.54	8	200 mg once weekly
0.55-0.63	9	225 mg once weekly
0.64-0.77	11	275 mg once weekly
0.78-0.83	12	300 mg once weekly
0.84-0.89	14	350 mg once weekly
0.90-1.05	15	375 mg once weekly
1.06-1.25	18	450 mg once weekly
1.26-1.39	21	525 mg once weekly
≥1.40	24	600 mg once weekly

). (

2.3 Recommended Dosage

The recommended dosage of OJEMDA based on body surface area (BSA) is 380 mg/m²orally once weekly (the maximum recommended dosage is 600 mg orally once weekly) with or without food

[see Administration (2.4)and Clinical Pharmacology (12.3)]

Table 1 Recommended OJEMDA Tablets Dosage Based on Body Surface Area
Body Surface Area (m²)	Recommended Dosage
0.30-0.89	Administer OJEMDA oral suspension once weekly (see Table 2)
0.90-1.12	400 mg once weekly
1.13-1.39	500 mg once weekly
≥ 1.40	600 mg once weekly

Table 2 Recommended Dosage for OJEMDA for Oral Suspension Based on Body Surface Area
Body Surface Area (m²)	Dose Volume (mL)OJEMDA for oral suspension has a concentration of 25 mg/mL. Each bottle of OJEMDA for oral suspension delivers 300 mg/12 mL.	Dosage
0.30-0.35	5	125 mg once weekly
0.36-0.42	6	150 mg once weekly
0.43-0.48	7	175 mg once weekly
0.49-0.54	8	200 mg once weekly
0.55-0.63	9	225 mg once weekly
0.64-0.77	11	275 mg once weekly
0.78-0.83	12	300 mg once weekly
0.84-0.89	14	350 mg once weekly
0.90-1.05	15	375 mg once weekly
1.06-1.25	18	450 mg once weekly
1.26-1.39	21	525 mg once weekly
≥1.40	24	600 mg once weekly

Continue once weekly dosing until disease progression or intolerable toxicity.

)

Administer OJEMDA orally, once weekly, with or without food. (

2.3 Recommended Dosage

The recommended dosage of OJEMDA based on body surface area (BSA) is 380 mg/m²orally once weekly (the maximum recommended dosage is 600 mg orally once weekly) with or without food

[see Administration (2.4)and Clinical Pharmacology (12.3)]

Table 1 Recommended OJEMDA Tablets Dosage Based on Body Surface Area
Body Surface Area (m²)	Recommended Dosage
0.30-0.89	Administer OJEMDA oral suspension once weekly (see Table 2)
0.90-1.12	400 mg once weekly
1.13-1.39	500 mg once weekly
≥ 1.40	600 mg once weekly

Table 2 Recommended Dosage for OJEMDA for Oral Suspension Based on Body Surface Area
Body Surface Area (m²)	Dose Volume (mL)OJEMDA for oral suspension has a concentration of 25 mg/mL. Each bottle of OJEMDA for oral suspension delivers 300 mg/12 mL.	Dosage
0.30-0.35	5	125 mg once weekly
0.36-0.42	6	150 mg once weekly
0.43-0.48	7	175 mg once weekly
0.49-0.54	8	200 mg once weekly
0.55-0.63	9	225 mg once weekly
0.64-0.77	11	275 mg once weekly
0.78-0.83	12	300 mg once weekly
0.84-0.89	14	350 mg once weekly
0.90-1.05	15	375 mg once weekly
1.06-1.25	18	450 mg once weekly
1.26-1.39	21	525 mg once weekly
≥1.40	24	600 mg once weekly

Continue once weekly dosing until disease progression or intolerable toxicity.

2.4 Administration

Take OJEMDA at a regularly scheduled time once weekly.
OJEMDA may be taken with or without food
[see Clinical Pharmacology (12.3)].

If a dose is missed by:

3 days or less, take the missed dose as soon as possible, and take the next dose on its regularly scheduled day.
more than 3 days, skip the missed dose and take the next dose on its regularly scheduled day.

If vomiting occurs immediately after taking a dose, repeat that dose.

OJEMDA tablets

Swallow tablets whole with water.
Do not chew, cut, or crush.

OJEMDA for oral suspension

Prior to first time use of OJEMDA for oral suspension, ensure that caregivers (and if appropriate, patients) read and understand the "Instructions for Use" before preparing, measuring, and administering OJEMDA.

Preparation and Administration

Reconstitute the powder in each supplied bottle with exactly 14 mL of room temperature water to form the OJEMDA for oral suspension. After reconstitution each mL contains 25 mg of tovorafenib. Product foaming after reconstitution reduces the deliverable volume.
Each bottle delivers 300 mg of tovorafenib in 12 mL. For doses greater than 300 mg, reconstitute two bottles to achieve the dose. Split the dose as equally as possible between the two bottles (e.g., 6 mL and 7 mL for a 325 mg dose). Prepare the first bottle and administer dose prior to preparing the second bottle.
Administer OJEMDA for oral suspension using the supplied oral dosing syringe or feeding tube (minimum 12 French) immediately after preparation.
If the OJEMDA for oral suspension is not administered within 15 minutes after preparation, instruct the patient to discard it.

Tablets
: Swallow tablets whole with water. Do not chew, cut, or crush. (
2.4 Administration
- Take OJEMDA at a regularly scheduled time once weekly.
- OJEMDA may be taken with or without food
  [see Clinical Pharmacology (12.3)].
If a dose is missed by:
- 3 days or less, take the missed dose as soon as possible, and take the next dose on its regularly scheduled day.
- more than 3 days, skip the missed dose and take the next dose on its regularly scheduled day.
If vomiting occurs immediately after taking a dose, repeat that dose.
OJEMDA tablets
Swallow tablets whole with water.
Do not chew, cut, or crush.
OJEMDA for oral suspension
Prior to first time use of OJEMDA for oral suspension, ensure that caregivers (and if appropriate, patients) read and understand the "Instructions for Use" before preparing, measuring, and administering OJEMDA.
Preparation and Administration
Reconstitute the powder in each supplied bottle with exactly 14 mL of room temperature water to form the OJEMDA for oral suspension. After reconstitution each mL contains 25 mg of tovorafenib. Product foaming after reconstitution reduces the deliverable volume.
Each bottle delivers 300 mg of tovorafenib in 12 mL. For doses greater than 300 mg, reconstitute two bottles to achieve the dose. Split the dose as equally as possible between the two bottles (e.g., 6 mL and 7 mL for a 325 mg dose). Prepare the first bottle and administer dose prior to preparing the second bottle.
Administer OJEMDA for oral suspension using the supplied oral dosing syringe or feeding tube (minimum 12 French) immediately after preparation.
If the OJEMDA for oral suspension is not administered within 15 minutes after preparation, instruct the patient to discard it.
)
For Oral Suspension
: See full prescribing information for preparation and administration instructions. (
2.4 Administration
- Take OJEMDA at a regularly scheduled time once weekly.
- OJEMDA may be taken with or without food
  [see Clinical Pharmacology (12.3)].
If a dose is missed by:
- 3 days or less, take the missed dose as soon as possible, and take the next dose on its regularly scheduled day.
- more than 3 days, skip the missed dose and take the next dose on its regularly scheduled day.
If vomiting occurs immediately after taking a dose, repeat that dose.
OJEMDA tablets
Swallow tablets whole with water.
Do not chew, cut, or crush.
OJEMDA for oral suspension
Prior to first time use of OJEMDA for oral suspension, ensure that caregivers (and if appropriate, patients) read and understand the "Instructions for Use" before preparing, measuring, and administering OJEMDA.
Preparation and Administration
Reconstitute the powder in each supplied bottle with exactly 14 mL of room temperature water to form the OJEMDA for oral suspension. After reconstitution each mL contains 25 mg of tovorafenib. Product foaming after reconstitution reduces the deliverable volume.
Each bottle delivers 300 mg of tovorafenib in 12 mL. For doses greater than 300 mg, reconstitute two bottles to achieve the dose. Split the dose as equally as possible between the two bottles (e.g., 6 mL and 7 mL for a 325 mg dose). Prepare the first bottle and administer dose prior to preparing the second bottle.
Administer OJEMDA for oral suspension using the supplied oral dosing syringe or feeding tube (minimum 12 French) immediately after preparation.
If the OJEMDA for oral suspension is not administered within 15 minutes after preparation, instruct the patient to discard it.
)

Lactation
: Advise not to breastfeed. (
8.2 Lactation
Risk Summary
There are no data on the presence of tovorafenib or its metabolites in human milk, their effects on the breastfed child, or on milk production. Due to the potential for serious adverse reactions in breastfed children from OJEMDA, advise lactating women not to breastfeed during treatment with OJEMDA and for 2 weeks following the last dose.
)
Infertility
: May impair fertility in males and females. (
8.3 Females and Males of Reproductive Potential
OJEMDA can cause fetal harm when administered to pregnant women
[see Use in Specific Populations (8.1)].
Pregnancy Testing
Verify pregnancy status in females of reproductive potential prior to initiating OJEMDA
[see Use in Specific Populations (8.1)]
.
Contraception
Females
Advise females of reproductive potential to use effective nonhormonal contraception during treatment with OJEMDA and for 28 days after the last dose. OJEMDA can render hormonal contraceptives ineffective
[see Drug Interactions (7.2)].
Males
Advise male patients with female partners of reproductive potential to use effective contraception during treatment with OJEMDA and for 2 weeks after the last dose.
Infertility
Based on findings in animals, OJEMDA may impact fertility in males and females of reproductive potential. The effects on male animal fertility were reversible. The effects on female animal fertility were not reversible
[see Nonclinical Toxicology (13.1)]
.
)

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