Astellas Launches XOSPATA® (gilteritinib) in the U.S.A

Astellas Pharma Inc. announced that XOSPATA® (generic name: gilteritinib) is now available for prescription in the United States for the treatment of adult patients who have relapsed or refractory (resistant to treatment) Acute Myeloid Leukemia (AML) with a FLT3 mutation as detected by an FDA-approved test.1 An oral monotherapy, XOSPATA is the first and only FLT3-targeting agent approved by the FDA for the treatment of relapsed or refractory FLT3 mutation-positive (FLT3mut+) AML.

XOSPATA was approved by the U.S. Food and Drug Administration (FDA) on November 28, 2018. Health professionals, patients and their caregivers can learn more about XOSPATA and support services provided through Astellas at

"Astellas aims to pursue cutting-edge science that provides value to patients," said Mark Reisenauer, senior vice president, oncology business unit, Astellas. "XOSPATA is an excellent example of how we are continuing to advance on this promise to patients."

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