FDA Approval Insights: Quizartinib in Newly Diagnosed, FLT3-ITD+ AML

Welcome to OncLive On Air^®! I’m your host today, Ashling Wahner.

OncLive On Air^® is a podcast from OncLive^®, which provides oncology professionals with the resources and information they need to provide the best patient care. In both digital and print formats, OncLive^® covers every angle of oncology practice, from new technology to treatment advances to important regulatory decisions.

In today’s episode, we had the pleasure of speaking with Mikkael A. Sekeres, MD, about the FDA approval of quizartinib (Vanflyta) in combination with chemotherapy in patients with newly diagnosed, FLT3-ITD–positive acute myeloid leukemia (AML). Dr Sekeres is a professor of medicine and chief of the Division of Hematology, Leukemia Section, at the University of Miami Health System in Florida.

On July 20, 2023, the FDA approved quizartinib plus standard cytarabine and anthracycline induction and cytarabine consolidation and as maintenance monotherapy after consolidation chemotherapy, for adult patients with newly diagnosed, FLT3-ITD–positive AML. This approval was supported by findings from the phase 3 QuANTUM-First trial (NCT02668653), in which, at a median follow-up of 32.9 months (interquartile range, 31.9-45.8), patients who received quizartinib plus chemotherapy achieved a median overall survival of 31.9 months (95% CI, 21.0-not estimable) vs 15.1 months (95% CI, 13.2-26.2) with placebo plus chemotherapy (HR, 0.78; 95% CI, 0.62-0.98; 2-sided P = .0324).

In our exclusive interview, Dr Sekeres discussed the significance of this approval, key efficacy and safety data from QuANTUM-First, and how this quizartinib regimen addresses an unmet need for older patients with FLT3-ITD–positive AML.

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