BRIEF—Daiichi Sankyo wins Priority Review for quizartinib

Daiichi Sankyo has been granted Priority Review status by the US regulator for the investigational acute myeloid leukemia (AML) therapy quizartinib.

The Japanese firm has applied to market the therapy for the treatment of adult patients with relapsed/refractory FLT3-ITD-positive AML. The FDA is expected to make a decision on approval by May 25, 2019.

AML franchise head Arnaud Lesegretain said: “Patients need more treatment options for this type of AML, which is particularly aggressive and difficult to treat.”

“Coupled with the recent acceptances of marketing applications for quizartinib in Japan and EU, we look forward to working with regulatory authorities in the USA, Japan and EU to bring quizartinib to patients.”