TOKYO, February 28, 2019 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) announced today that the submission for a marketing authorisation application (MAA) for the oral once-daily therapy XOSPATA (gilteritinib) for the treatment of adult patients who have relapsed or refractory (resistant to treatment) acute myeloid leukaemia (AML) with a FLT3 mutation (FLT3mut+) has been accepted by the European Medicines Agency for regulatory review.

Astellas applied for and received accelerated assessment from the European Medicines Agency (EMA) for gilteritinib, which means the Committee for Medicinal Products for Human Use (CHMP) can reduce the timeframe for approval from 210 to 150 days.1 

The MAA is based on data from the Phase 3 ADMIRAL trial investigating gilteritinib for the treatment of adult patients with FLT3mut+ relapsed or refractory AML. The full results of the ADMIRAL trial will be presented at the American Association for Cancer Research (AACR) Annual Meeting 2019, March 29 – April 3 in Atlanta, USA.

AML is a cancer that impacts the blood and bone marrow, and its incidence increases with age.2  The incidence rate of AML is 3.7 per 100,000 per year in the European Union, resulting in an estimated 18,400 individuals diagnosed.3