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FDA Approves Addition of Survival Data to Gilteritinib Label for Refractory AML with a FLT3 Mutation

The Food and Drug Administration approved the addition of overall survival data in labeling for gilteritinib (XOSPATA, Astellas Pharma US, Inc.), indicated for adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation as detected by an FDA-approved test.