| Leukemia, Myelocytic, Acute
Mylotarg vs Xospata
Side-by-side clinical, coverage, and cost comparison for leukemia, myelocytic, acute.Deep comparison between: Mylotarg vs Xospata with Prescriber.AI
AI compares prescribing info and payer-specific access barriers across 1,200+ formularies. Here's a preview of what prescribers are already asking.Safety signalsXospata has a higher rate of injection site reactions vs Mylotarg based on FDA-approved prescribing information
Coverage gaps3 major payers require step therapy for Xospata but not Mylotarg, including UnitedHealthcare
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Category
Mylotarg
Xospata
At A Glance
IV infusion
CD33-directed antibody-drug conjugate (ADC)
Oral
Daily
FLT3 inhibitor
Indications
- Leukemia, Myelocytic, Acute
- Leukemia, Myelocytic, Acute
Dosing
Leukemia, Myelocytic, Acute - newly-diagnosed, combination regimen Adults: Induction 3 mg/m2 (up to one 4.5 mg vial) IV on Days 1, 4, and 7 with daunorubicin and cytarabine; Consolidation 3 mg/m2 IV on Day 1 with daunorubicin and cytarabine. Pediatric patients 1 month and older: 3 mg/m2 (BSA >=0.6 m2) or 0.1 mg/kg (BSA <0.6 m2) IV.
Leukemia, Myelocytic, Acute - newly-diagnosed, single-agent Adults: Induction 6 mg/m2 IV on Day 1 and 3 mg/m2 on Day 8; Continuation 2 mg/m2 IV on Day 1 every 4 weeks for up to 8 cycles.
Leukemia, Myelocytic, Acute - relapsed or refractory Adults and pediatric patients 2 years and older: 3 mg/m2 (up to one 4.5 mg vial) IV on Days 1, 4, and 7 as a single course.
Leukemia, Myelocytic, Acute 120 mg orally once daily with or without food; in the absence of disease progression or unacceptable toxicity, treat for a minimum of 6 months to allow time for a clinical response.
Contraindications
- Known hypersensitivity to gemtuzumab ozogamicin, its components, or any excipient (reactions have included anaphylaxis)
- Hypersensitivity to gilteritinib or any of the excipients
Adverse Reactions
Most common Infection, febrile neutropenia, hemorrhage, thrombocytopenia, neutropenia, decreased appetite, hyperglycemia, mucositis, transaminase increased, fatigue, nausea
Serious Hepatotoxicity including veno-occlusive disease (VOD), infusion-related reactions, hemorrhage, prolonged thrombocytopenia, prolonged neutropenia
Postmarketing Neutropenic colitis (including fatal events), fungal lung infections (Pulmonary mycosis, Pneumocystis jirovecii pneumonia), Stenotrophomonas bacterial infection, hemorrhagic cystitis, interstitial pneumonia
Most common (>=10%) transaminase increased, myalgia/arthralgia, fatigue/malaise, fever, mucositis, edema, rash, noninfectious diarrhea, dyspnea, nausea, cough, constipation, eye disorders, headache, dizziness, hypotension, vomiting, renal impairment, abdominal pain, neuropathy, insomnia, dysgeusia
Serious differentiation syndrome, posterior reversible encephalopathy syndrome, prolonged QT interval, pancreatitis
Pharmacology
Gemtuzumab ozogamicin is a CD33-directed antibody-drug conjugate (ADC) that binds CD33-expressing tumor cells, undergoes internalization of the ADC-CD33 complex, and releases N-acetyl gamma calicheamicin dimethyl hydrazide intracellularly via hydrolytic linker cleavage; the activated calicheamicin derivative induces double-strand DNA breaks, leading to cell cycle arrest and apoptotic cell death.
Gilteritinib is a small molecule inhibitor of multiple receptor tyrosine kinases, including FLT3; it inhibits FLT3 receptor signaling and proliferation in cells expressing FLT3-ITD and FLT3 tyrosine kinase domain mutations, and induces apoptosis in leukemic cells expressing FLT3-ITD.
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Most Common Insurance
Anthem BCBS
Mylotarg
- Covered on 5 commercial plans
- PA (10/12) · Step Therapy (4/12) · Qty limit (0/12)
Xospata
- Covered on 5 commercial plans
- PA (11/12) · Step Therapy (3/12) · Qty limit (12/12)
UnitedHealthcare
Mylotarg
- Covered on 4 commercial plans
- PA (1/8) · Step Therapy (0/8) · Qty limit (0/8)
Xospata
- Covered on 4 commercial plans
- PA (8/8) · Step Therapy (0/8) · Qty limit (4/8)
Humana
Mylotarg
- Covered on 0 commercial plans
- PA (2/3) · Step Therapy (0/3) · Qty limit (0/3)
Xospata
- Covered on 0 commercial plans
- PA (3/3) · Step Therapy (0/3) · Qty limit (2/3)
Coverage data sourced from MMIT. Updated monthly.
Savings
Cost estimate not availableAssistance Fund: Acute Myeloid Leukemia
Commercial or private insurance
Medicare, Medicaid, VA, TRICARE
Cost estimate not availableAssistance Fund: Acute Myeloid Leukemia
Commercial or private insurance
Medicare, Medicaid, VA, TRICARE
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Clinical data sourced from FDA-approved labeling. Coverage data via MMIT. Updated monthly.