Daiichi Sankyo’s Quizartinib Gets Priority Review for Newly Diagnosed Leukemia

The FDA has granted Priority Review to Daiichi Sankyo’s 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 NDA is supported by results from a phase 3 trial in which the treatment regimen showed a statistically significant improvement in overall survival compared to chemotherapy alone.

Quizartinib inhibits ITD (internal tandem duplication) mutations that cause an aggressive form of blood cancer. The investigational drug had previously received Fast Track and Orphan Drug designations.

The FDA’s decision date for this application is on April 24, 2023.