Nearly five years after submitting its first NDA seeking U.S. approval for Vanflyta (quizartinib) for treating a subset of patients with acute myeloid leukemia (AML), Daiichi Sankyo Co. Ltd. finally cleared the last hurdle. The FDA on July 20 approved the FLT3 inhibitor for use in combination with cytarabine and anthracycline induction and cytarabine consolidation, and as maintenance monotherapy following consolidation chemotherapy, for the treatment of adult patients with newly diagnosed disease that is FLT3 ITD-positive.