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# FDA OKs Vanflyta for Leukemia
- URL: https://www.fdaweb.com/fda-oks-vanflyta-for-leukemia/
- Published: 2023-07-20T12:00:00.000Z
- Updated: 2026-09-14T18:45:19.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5154925

FDA has approved a Daiichi Sankyo NDA for Vanflyta (quizartinib) in certain patients with newly diagnosed acute myeloid leukemia (AML) that is FLT3 internal tandem duplication (ITD)-positive. The approval covers Vanflyta use with standard cytarabine and anthracycline induction and cytarabine consolidation, and as maintenance monotherapy following consolidation chemotherapy. In a simultaneous action, the agency approved the LeukoStrat CDx FLT3 Mutation Assay as a companion diagnostic.

The drug was approved based on data from QuANTUM-First (NCT02668653), a randomized, double-blind, placebo-controlled trial in 539 patients with newly diagnosed FLT3-ITD positive AML, according to an agency [news release](https://www.fda.gov/drugs/drug-approvals-and-databases/fda-approves-quizartinib-newly-diagnosed-acute-myeloid-leukemia?ref=fdaweb.com). The main efficacy outcome measure was overall survival (OS), measured from randomization date until death by any cause. “The trial demonstrated a statistically significant improvement in OS for the quizartinib arm,” it says.

FDA says a boxed warning for quizartinib highlights QT prolongation, torsades de pointes, and cardiac arrest. It notes that the drug is available only through a restricted program under a Risk Evaluation and Mitigation Strategy.