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.[1] 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. [1]

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.[2][3] The American Cancer Society estimates that in 2018, approximately 19,000 people will be diagnosed with AML in the U.S.[3]

“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.”

[1] XOSPATA [package insert]. Northbrook, IL: Astellas Pharma US, Inc.
[2] American Cancer Society. What is acute myeloid leukemia? Last accessed December 2, 2018
[3] American Cancer Society. Key statistics for acute myeloid leukemia Last accessed December 2, 2018.

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