Quizartinib NDA review for patients with newly diagnosed FLT3-ITD positive AML is extended by FDA to 24 July 2023
Daiichi Sankyo announced that the FDA has extended the review period for the New Drug Application (NDA) of quizartinib in combination with standard cytarabine and anthracycline induction and standard cytarabine consolidation chemotherapy, and as continuation monotherapy following consolidation, for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) that is FLT3-ITD positive
The FDA has extended the Prescription Drug User Fee Act (PDUFA) action date by three months to 24 July 2023, to allow additional time to review requested updates to the proposed Risk Evaluation and Mitigation Strategies (REMS) included in this application. No additional efficacy or safety data has been requested.
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