Posted by Michael Wonder on 22 Nov 2018
FDA grants priority review for Daiichi Sankyo’s new drug application for FLT3 inhibitor quizartinib for treatment of patients with relapsed/refractory FLT3-ITD AML
22 November 2018 - Quizartinib marketing applications now under expedited review in the U.S., Japan and EU.
Daiichi Sankyo announced that the U.S. FDA has accepted a new drug application and granted priority review for quizartinib for the treatment of adult patients with relapsed/refractory FLT3-ITD acute myeloid leukaemia.
The FDA is expected to make a decision on approval by 25 May 2019.
