Astellas Xospata Approved for Acute Myeloid Leukemia

FDA has approved Astellas Pharma’s Xospata (gilteritinib) tablets for treating adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation as detected by an FDA-approved test. The agency also approved an expanded indication for a companion diagnostic, Invivoscribe Technologies’ LeukoStrat CDx FLT3 Mutation Assay.

Approval was based on clinical trial data from 138 patients with relapsed or refractory AML having a confirmed FLT3 mutation, an agency release says. “Twenty-one percent of patients achieved complete remission (no evidence of disease and full recovery of blood counts) or complete remission with partial hematologic recovery (no evidence of disease and partial recovery of blood counts) with treatment,” it says. “Of the 106 patients who required red blood cell or platelet transfusions at the start of treatment with Xospata, 31% became transfusion-free for at least 56 days.”