FDA Panel Votes Against Quizartinib Approval for AML

May 14, 2019 – The FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 8-3 against approving a new drug application (NDA) for quizartinib for adult patients with relapsed/refractory FLT3-ITD–positive acute myeloid leukemia (AML). The FDA is now scheduled to make a final decision on the NDA for the FLT3 inhibitor by August 25, 2019. The NDA was filed based on findings from the phase III QuANTUM-R study, in which quizartinib reduced the risk of death by … (leggi tutto)