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.
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