The FDA granted priority review to quizartinib for the treatment of patients with relapsed or refractory FLT3-ITD acute myeloid leukemia.
The agency is expected to make a decision on the application by May 25.
Quizartinib (Daiichi Sankyo) is an oral, selective FLT3 inhibitor. FLT3-ITD is the most common FLT mutation, occurring among 25% of patients with AML.
The FDA based the designation on results of the randomized phase 3 QuANTUM-R study, which included 367 patients with FLT3-ITD AML who were refractory to or relapsed no more than 6 months after standard first-line therapy.
Results showed quizartinib prolonged OS compared with salvage chemotherapy.
The most common adverse drug reactions among quizartinib-treated patients included infections, bleeding, nausea, asthenic conditions, pyrexia, febrile neutropenia and vomiting. The most common grade 3 or higher adverse drug reactions were infection and febrile neutropenia.
“If approved, quizartinib has the potential to meaningfully advance treatment for patients with relapsed or refractory FLT3-ITD AML. Patients need more treatment options for this type of AML, which is particularly aggressive and difficult to treat,” Arnaud Lesegretain, vice president for oncology research and development and head of the AML franchise at Daiichi Sankyo, said in a company-issued press release.
The FDA previously granted breakthrough therapy designation to quizartinib for this indication, as well as fast track designation for the treatment of relapsed or refractory AML.