Posted by Michael Wonder on 21 Sep 2019
Astellas receives positive CHMP opinion for Xospata (gilteritinib) as a monotherapy for patients with relapsed or refractory acute myeloid leukaemia with a FLT3 mutation
20 September 2019 - If approved by the European Commission, gilteritinib would represent one of the few advances in Europe for AML over the past 40 years.
Astellas Pharma announced today that the CHMP of the EMA has adopted a positive opinion recommending the oral once-daily therapy Xospata (gilteritinib) as a monotherapy for the treatment of adult patients who have relapsed or refractory (resistant to treatment) acute myeloid leukaemia with a FLT3 mutation.
Gilteritinib received accelerated assessment from the EMA, which allowed the CHMP to reduce the timeframe for approval.
