Gilteritinib (Xospata®; Astellas Pharma) 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. An oral monotherapy, gilteritinib is the first and only FLT3-targeting agent approved by the U.S. Food and Drug Administration (FDA) for the treatment of relapsed or refractory Acute Myeloid Leukemia (AML) with a FMS-like tyrosine kinase 3 (FLT3) mutation as detected by an FDA-approved test. 
Gilteritinib was discovered through a research collaboration with Kotobuki Pharmaceutical. The drug was approved by the U.S. Food and Drug Administration (FDA) on November 28, 2018.
Acute Myeloid Leukemia
Acute Myeloid Leukemia (AML) is a cancer that impacts the blood and bone marrow,2 and its incidence increases with age. The American Cancer Society estimates that in 2018, approximately 19,000 people will be diagnosed with AML in the U.S.
“Astellas aims to pursue cutting-edge science that provides value to patients,” said Mark Reisenauer, senior vice president, oncology business unit, Astellas. “[Gilteritinib] is an excellent example of how we are continuing to advance on this promise to patients.”
 XOSPATA [package insert]. Northbrook, IL: Astellas Pharma US, Inc.
 American Cancer Society. What is acute myeloid leukemia? Last accessed December 2, 2018
 American Cancer Society. Key statistics for acute myeloid leukemia Last accessed December 2, 2018.
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