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# FDA Rejects Daiichi Sankyo Quizartinib NDA
- URL: https://www.fdaweb.com/fda-rejects-daiichi-sankyo-quizartinib-nda/
- Published: 2019-06-25T12:00:00.000Z
- Updated: 2026-09-15T01:34:40.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5144424

FDA has sent Daiichi Sankyo a complete response letter on its NDA for quizartinib for treating adults with relapsed/refractory FLT3-ITD acute myeloid leukemia (AML). Quizartinib, an oral selective Type II FLT3 inhibitor, was approved earlier this month by Japan under the brand name Vanflyta for the same indication. The company says that a clinical development program is underway with quizartinib in combination with standard chemotherapy in newly diagnosed FLT3-ITD AML (QuANTUM-First) in the U.S., EU and Japan, according to the company.