FDA’s priority review to quizartinib for FLT-3 mutant AML patients

November 2022 Pharma News Nalinee Pathak
AML Acute Myeloid Leukemia acronym on colorful wooden cubes

The FDA has prioritised reviewing quizartinib, a selective inhibitor of FLT-3, for a subgroup of patients with acute myeloid leukaemia (AML).  The priority has been awarded based on the findings of the QuANTUM-First trial.

FMS-like tyrosine kinase 3 (FLT3)- internal tandem duplication (ITD) is a common driver mutation in approximately 25% of AML cases. It is associated with unfavourable clinical outcomes and shorter overall survival (OS). Daiichi Sankyo has developed a selective oral inhibitor of FLT-3, quizartinib, whose efficacy has been evaluated in the phase III QuANTUM-First trial.

QuANTUM-First trial

The randomized phase III QuANTUM-First trial enrolled 539 AML patients (median age 56 years) with FLT3-ITD mutations. The participants were randomized (1:1) to either receive quizartinib (n=268) or placebo (n=271) in combination with standard induction (cytarabine and anthracycline) and consolidation chemotherapy (cytarabine). The study’s primary endpoint was OS, whereas the secondary endpoints included event-free survival (EFS), complete remission (CR), composite CR, and safety.


After a median follow-up of 39.2 months, the OS was improved in the quizartinib arm as compared to the placebo (median 31.9 months vs 15.1 months; HR [95% CI]: 0.77 [0.61-0.97]). The safety profile of quizartinib was found to be manageable.


There is an unmet need for treating AML patients with FLT-3 mutations. Therefore, the FDA’s priority for quizartinib reflects the promising results of the QuANTUM-First trial and the potential the drug combination has for changing clinical outcomes in AML.


  1. Daiichi Sankyo. Quizartinib Granted Priority Review in the U.S. for Patients with Newly Diagnosed FLT3-ITD Positive Acute Myeloid Leukemia.