XOSPATA® (Gilteritinib)

The FDA on May 29, 2019 approved the addition of overall survival data in labeling for XOSPATA®, indicated for adult patients who have relapsed or refractory Acute Myeloid Leukemia (AML) with a FLT3 mutation, as detected by an FDA-approved test. XOSPATA® is a product of Astellas Pharma US, Inc.