Quizartinib filed with FDA and given priority review for acute myeloid leukemia

The application has been granted Priority Review.

Quizartinib had been filed with the FDA in 2019 but received a complete response letter. The Prescription Drug User Fee Act date (PDUFA), the FDA action date for their regulatory decision, is April 24, 2023. The Priority Review follows receipt of Fast Track Designation, granted by the FDA in March 2022 for quizartinib in newly diagnosed FLT3-ITD positive AML.

The NDA is based on data from the QuANTUM-First phase III trial presented at the Presidential Symposium of the European Hematology Association (EHA) 2022 Congress. In QuANTUM-First, quizartinib combined with standard cytarabine and anthracycline induction and standard cytarabine consolidation chemotherapy, and continued as monotherapy following consolidation, demonstrated a statistically significant and clinically meaningful improvement in overall survival in adult patients with newly diagnosed FLT3-ITD positive AML compared to chemotherapy alone.

The safety of quizartinib combined with intensive chemotherapy and as continuation monotherapy in QuANTUM-First was generally manageable with no new safety signals observed. The incidence of grade ?3 QT prolongation events was low, with uncommon ventricular arrythmia events. Overall, the risk of QT prolongation was manageable with ECG monitoring, quizartinib dose modification and correction/elimination of additional risk factors.