Datapoint: FDA Approves Vanflyta in AML

The FDA on July 20 approved Daiichi Sankyo’s FLT3 inhibitor Vanflyta (quizartinib) for the treatment of FLT3-ITD positive acute myeloid leukemia (AML) in newly diagnosed adult patients, in combination with standard induction and consolidation chemotherapies. The drug was also approved as a maintenance monotherapy following consolidation chemotherapy. And while Vanflyta is the first FLT3 inhibitor to be approved across all three phases of treatment in newly diagnosed AML, it will still have to face off against Astella’s Xospata and Novartis’ Rydapt, which also target FLT3 mutations in AML. Both therapies have a strong hold on the market. Under the pharmacy benefit, Xospata currently holds covered or better status for 95% of all insured lives, to Rydapt’s 98%.

SOURCE: MMIT Analytics, as of 7/24/23

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