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 plans to launch the drug, which it said is the first approved in the indication, in the coming days at a wholesale acquisition cost (WAC) of $22,500 for a 30-day course of treatment.

In conjunction with the approval, FDA approved an expanded indication for the companion diagnostic LeukoStrat CDx FLT3 Mutation Assay from Invivoscribe Technologies Inc. (San Diego, Calif.). The test determines which AML patients harbor the FLT3 mutation...