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# Daiichi Sankyo Quizartinib NDA for Acute Myeloid Leukemia
- URL: https://www.fdaweb.com/daiichi-sankyo-quizartinib-nda-for-acute-myeloid-leukemia/
- Published: 2018-11-21T12:00:00.000Z
- Updated: 2026-09-15T00:46:13.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5142877

FDA has accepted for priority review a Daiichi Sankyo NDA for quizartinib for treating adult patients with relapsed/refractory FLT3-ITD acute myeloid leukemia (AML). The agency set a user fee review action target date of 5/25/2019.

The NDA is based on results from the Phase 3 QuANTUM-R study of quizartinib, which showed that the FLT3 inhibitor prolonged overall survival compared to chemotherapy in patients with relapsed/refractory FLT3-ITD AML. The most common adverse drug reactions in patients treated with quizartinib included infections, bleeding, nausea, asthenic conditions, pyrexia, febrile neutropenia and vomiting.