Quizartinib (Vanflyta)

Canada’s Drug Agency (CDA-AMC) recommends that Vanflyta should be reimbursed by public drug plans for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) with an FMS-like tyrosine kinase 3 internal tandem duplication (FLT3-ITD) mutation if certain conditions are met. Vanflyta, in combination with standard cytarabine and anthracycline induction and standard cytarabine consolidation chemotherapy followed by maintenance monotherapy with Vanflyta, should only be covered to treat patients with newly diagnosed primary AML or AML secondary to myelodysplastic syndrome or a myeloproliferative neoplasm, and with good performance status. The presence of an FLT3-ITD–activating mutation in bone marrow should be identified using a validated test. Vanflyta should only be reimbursed if treatment is initiated by clinicians with expertise in managing AML in institutions with expertise in systemic therapy delivery. Vanflyta should be negotiated so that the total treatment cost does not exceed the drug program cost of treatment with midostaurin reimbursed for the treatment of adult patients with newly diagnosed AML that is FLT3-ITD positive.