28 February 2019 - Astellas Pharma announced today that the submission for a marketing authorisation application 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 with a FLT3 mutation has been accepted by the European Medicines Agency for regulatory review.

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

The application 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 Annual Meeting 2019, March 29 – April 3 in Atlanta, USA.

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