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# FDA Extends Review of Daiichi Leukemia NDA
- URL: https://www.fdaweb.com/fda-extends-review-of-daiichi-leukemia-nda/
- Published: 2023-04-21T12:00:00.000Z
- Updated: 2026-09-14T18:27:02.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5154272

FDA has extended by three months its review of a Daiichi Sankyo NDA resubmisson for quizartinib in combination with standard cytarabine and anthracycline induction and standard cytarabine consolidation chemotherapy for treating adult patients with newly diagnosed (FTL3-ITP positive) acute myeloid leukemia (AML). The revised user fee action target date is 7/24, which allows additional time to review requested updates to the proposed Risk Evaluation and Mitigation Strategies included in the submission, according to the company. It says that no additional efficacy or safety data have been requested.

The submission is based on data from the [QuANTUM-First](https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fclinicaltrials.gov%2Fct2%2Fshow%2FNCT02668653&esheet=53384837&newsitemid=20230420005738&lan=en-US&anchor=QuANTUM-First&index=1&md5=85c4907ad8ac0ce99d9c611241f74308&ref=fdaweb.com) trial, which the company says “demonstrated that quizartinib combined with standard cytarabine and anthracycline induction and standard cytarabine consolidation chemotherapy, and continued as monotherapy following consolidation, resulted in a statistically significant and clinically meaningful improvement in overall survival in adult patients with newly diagnosed FLT3-ITD positive AML compared to chemotherapy alone.”