Daiichi Sankyo's Vanflyta approved for new AML indication in Japan

25 May 2023

Japanese drugmaker Daiichi Sankyo (TYO:4568) today announced that Vanflyta (quizartinib) has been approved in Japan for the treatment of acute myeloid leukemia (AML) that is FLT3-ITD mutation positive, with the news surprisingly pushing the firm’s shares down 4.4% to 4,582 yen

Vanflyta is now approved to treat patients with newly diagnosed FLT3-ITD positive AML in combination with standard cytarabine and anthracycline induction and standard cytarabine consolidation chemotherapy and as maintenance monotherapy, making it the first and only FLT3 inhibitor in Japan approved for newly diagnosed AML treatment.

Vanflyta was first approved in 2019 in Japan as a monotherapy in the relapsed/refractory setting. It is under review in the USA for the first-line treatment of adults with FLT3-ITD-positive AML. The US Food and Drug Administration recently said needs more time to review requested updates to the proposed Risk Evaluation and Mitigation Strategies (REMS). The new target date for a decision on the submission is July 24.

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