Xospata poised for EU approval under accelerated assessment

EMA's CHMP recommended approval of Xospata for acute myelogenous leukemia in its September roundup.

Under accelerated assessment, the agency backed Xospata gilteritinib from Astellas Pharma Inc. (Tokyo:4503) as monotherapy for relapsed or refractory AML in patients with a FLT3 mutation. The oral small molecule AXL and FLT3 inhibitor has U.S. and Japanese approval in the indication. ...