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Approval of Daiichi Sankyo’s Vanflyta Sets Up FLT3 Head-To-Head Competition

 
• By Alaric DeArment

After over a decade in development, Vanflyta scored FDA approval in newly diagnosed FLT3-ITD acute myeloid leukemia, where Novartis FLT3 inhibitor Rydapt has been on the market for years.

The FDA approved Daiichi Sankyo's Vanflyta in FLT3-ITD first-line AML • Source: Shutterstock

It took several years, but Daiichi Sankyo Co., Ltd.’s Vanflyta (quizartinib) has finally crossed the finish line in the US, with the Food and Drug Administration approving the drug, giving it a first-line acute myeloid leukemia (AML) label that sets it up as a competitor for Novartis AG’s Rydapt (midostaurin).

The FDA cleared Vanflyta on 20 July – just before its 24 July action date – in combination with cytarabine and anthracycline induction and following cytarabine consolidation. The agency also approved the drug as a monotherapy maintenance treatment following consolidation chemotherapy

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