Review delay adds to Daiichi Sankyo's quizartinib woes

The US Food and Drug Administration (FDA) has extended the review period for Daiichi Sankyo’s (TYO: 4568) quizartinib.

The candidate, an investigational FLT3 inhibitor, was granted priority review for the treatment of adult patients with relapsed or refractory FLT3-ITD acute myeloid leukemia (AML) in November.

According to the FDA, the data provided were not sufficient to approve the application. The new Prescription Drug User Fee Act (PDUFA) is August 25, giving the FDA time to review additional data submitted by the Japanese pharma major.