FDA nod for Astellas AML drug

The US Food and Drug Administration on Wednesday approved Xospata (gilteritinib) tablets for the treatment of adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation as detected by an FDA-approved test.

The FDA granted the approval of Xospata to Japanese major Astellas Pharma (TYO: 4503), marking its entry into the US blood cancer treatment sector, and sending the company’s shares up 2.33% to 1,712 yen today.

The FDA also approved an expanded indication for a companion diagnostic, to include use with Xospata. The LeukoStrat CDx FLT3 Mutation Assay, developed by Invivoscribe Technologies, is used to detect the FLT3 mutation in patients with AML.