EMA accepts Xospata for regulatory review

Japanese drug major Astellas Pharma (TYO: 450) says its marketing authorization 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 leukemia (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 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.

The MAA is based on data from the Phase III 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.