FDA approves Vanflyta + chemotherapy to treat newly diagnosed acute myeloid leukemia (AML) that is FLT3-ITD positive
Daiichi Sankyo announced that Vanflyta (quizartinib) has been approved by the FDA in combination with standard cytarabine and anthracycline induction and cytarabine consolidation, and as maintenance monotherapy following consolidation chemotherapy, for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) that is FLT3-ITD positive as detected by an FDA-approved test
Vanflyta is not indicated as maintenance monotherapy following allogeneic hematopoietic stem cell transplantation (HSCT); improvement in overall survival with Vanflyta in this setting has not been demonstrated.
AML is one of the most common forms of leukemia in adults and an estimated 20,380 new cases will be diagnosed in the U.S. in 2023. Up to 37% of newly diagnosed patients with AML have a FLT3 gene mutation and approximately 80% of these are FLT3-ITD mutations, which drive cancer growth and contribute to increased risk of relapse and shorter overall survival. The five-year survival rate for patients with FLT3-ITD AML has been reported at approximately 20%.
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