The Food and Drug Administration (FDA) has extended the review period for the New Drug Application (NDA) for quizartinib in combination with standard cytarabine and anthracycline induction and standard cytarabine consolidation chemotherapy, and as continuation monotherapy following consolidation, for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) that is FLT3-ITD positive.
The new Prescription Drug User Fee Act target date is now July 24, 2023. The FDA extended the target date by 3 months to allow time to review requested updates to the proposed Risk Evaluation and Mitigation Strategies in the application.
Quizartinib is an oral, highly potent type II FLT3 inhibitor that selectively targets FLT3-ITD mutations. The NDA is supported by data from the randomized, double-blind, placebo-controlled phase 3 QuANTUM First study (ClinicalTrials.gov Identifier: NCT02668653), which compared the efficacy and safety of quizartinib to placebo in combination with standard cytarabine and anthracycline induction and standard cytarabine consolidation chemotherapy, and then as continued single agent therapy, in adults with newly diagnosed AML that is FLT3-ITD positive.
Findings showed a 22.4% reduction in the risk of death with quizartinib compared with chemotherapy alone (hazard ratio [HR], 0.776; 95% CI, 0.615-0.979; 2-sided P =.0324). After a median follow-up of 39.2 months, median overall survival was 31.9 months (95% CI, 21.0-NE) for the quizartinib arm compared with 15.1 months (95% CI, 13.2-26.2) for the chemotherapy arm.
With regard to safety, the incidence of grade 3 or higher QT prolongation events was found to be low with quizartinib. This risk was reported to be manageable with ECG monitoring, dose modification and correction/elimination of additional risk factors.
“We are continuing to work with the FDA to facilitate completion of their review of the quizartinib new drug application in order to bring this important medicine to patients as soon as possible,” said Mark Rutstein, MD, Global Head, Oncology Clinical Development, Daiichi Sankyo. “Quizartinib was shown to improve overall survival when added to standard chemotherapy and continued as monotherapy and has potential to change the standard of care for patients with newly diagnosed FLT3-ITD positive AML.”
This article originally appeared on MPR