FDA approves Astellas’ Xospata in FLT3-positive AML

FDA approved Xospata gilteritinib from Astellas Pharma Inc. (Tokyo:4503) to treat relapsed or refractory acute myelogenous leukemia in patients with an FMS-like tyrosine kinase 3 (FLT3; CD135) mutation. The company said Xospata is the first FDA-approved drug in the indication.

On Nov. 28, Astellas said it plans to launch Xospata in the coming days at a wholesale acquisition cost (WAC) of $22,500 for a 30-day course of treatment...