Daiichi Sankyo received notification of acceptance by the U.S. Food and Drug Administration (FDA) of 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 application has been granted Priority Review.

The FDA grants Priority Review to applications for medicines that, if approved, would offer significant improvements over available options by demonstrating safety or efficacy improvements, preventing serious conditions or enhancing patient compliance. The Prescription Drug User Fee Act date (PDUFA), the FDA action date for their regulatory decision, is April 24, 2023. The Priority Review follows receipt of Fast Track Designation, granted by the FDA in March 2022 for quizartinib in newly diagnosed FLT3-ITD positive AML.

AML is one of the most common forms of leukemia in adults.1 An estimated 20,050 new cases of AML will be diagnosed in the U.S. in 2022, and the five-year overall survival rate is reported at 30.5%.

Of all newly diagnosed cases of AML, approximately 25% have the FLT3-ITD mutation, which is associated with particularly unfavorable prognosis including increased risk of relapse and shorter overall survival.

“There is a need for new targeted therapy options for patients with acute myeloid leukemia and the results of the QuANTUM-First trial showed that quizartinib in combination with standard chemotherapy has potential to change the current standard of care for newly diagnosed patients with the historically difficultto-treat FLT3-ITD subtype,” said Ken Takeshita, MD, Global Head, R&D, Daiichi Sankyo.

“The FDA’s prioritization of this application reflects the importance of the data, and we will continue to work with the FDA and other global regulatory authorities to support the review of quizartinib for the treatment of patients with newly diagnosed FLT3-ITD positive acute myeloid leukemia.”