Quizartinib granted approval in Japan for the treatment of patients with newly diagnosed AML with FLT3-ITD mutations

On May 25, 2023, quizartinib, an oral, highly potent and selective type II FLT3 inhibitor was approved by Japan’s Ministry of Health, Labour, and Welfare (MHLW) for the treatment of patients with newly diagnosed acute myeloid leukemia (AML) with FLT3-internal tandem duplication (FLT3-ITD) mutations.¹

This approval is for use in combination with standard cytarabine and anthracycline induction, standard cytarabine consolidation chemotherapy, and as maintenance monotherapy. Quizartinib is the first FLT3 inhibitor approved for newly diagnosed patients with AML in Japan, having received approval in 2019 as a monotherapy in the relapsed/refractory AML setting.¹

This approval is based on the results from the randomized, double-blind, placebo-controlled, phase III QuANTUM-First trial (NCT02668653), which has been previously covered on the AML Hub. In this trial, the addition of quizartinib to standard cytarabine and anthracycline induction and standard cytarabine consolidation, and quizartinib maintenance monotherapy was associated with a 22.4% reduction in the risk of death when compared with standard chemotherapy alone (hazard ratio, 0.78; 95% confidence interval [CI], 0.62–0.98; p = 0.032).¹ Median overall survival in the quizartinib arm (n = 268) was 31.9 months (95% CI, 21.0–NE) compared with 15.1 months (95% CI, 13.2–26.2) in the standard chemotherapy arm (n = 271).¹ The most common adverse reactions in patients who received quizartinib were neutropenia (25.0%), thrombocytopenia (22.7%), nausea (20.6%), and electrocardiogram QT prolonged (19.3%), consistent with previous reports.¹