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# Review Extended on Daiichi Leukemia Drug
- URL: https://www.fdaweb.com/review-extended-on-daiichi-leukemia-drug/
- Published: 2019-04-04T12:00:00.000Z
- Updated: 2026-09-15T01:18:28.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5143791

FDA has extended by three months the review of a Daiichi Sankyo NDA for quizartinib, an investigational FLT3 inhibitor currently under priority review for treating adult patients with relapsed/refractory FLT3-ITD acute myeloid leukemia (AML). The extension is necessary for FDA to review a agency-requested data submission, according to the company. The new user fee review action date is 8/25.

The original submission was based on data from the Phase 3 QuANTUM-R study of quizartinib, which Daiichi Sankyo says was the first randomized Phase 3 study to show that a FLT3 inhibitor prolonged overall survival as an oral, single agent compared to chemotherapy in patients with relapsed/refractory FLT3-ITD AML. FLT3 gene mutations are one of the most common genetic abnormalities in AML, the company says.