Posted by Michael Wonder on 30 May 2018
U.S. FDA grants priority review to Astellas’ new drug application for gilteritinib for the treatment of adult patients with relapsed or refractory acute myeloid leukaemia
29 May 2018 - Astellas announced today that the U.S. FDA has accepted, with priority review, the company’s new drug application for gilteritinib for the treatment of adult patients who have relapsed or refractory acute myeloid leukaemia with a FLT3 mutation as detected by an FDA-approved test.
Currently, there are no FLT3-targeting agents approved for the treatment of relapsed or refractory FLT3 mutation-positive (FLT3mut+) acute myeloid leukaemia (AML).
The application is based on the ongoing Phase 3 ADMIRAL trial investigating gilteritinib for the treatment of adult patients with FLT3mut+ relapsed or refractory AML. The Prescription Drug User Fee Act goal date for a decision by the FDA is 29 November 2018.
