TOKYO, April 10, 2020 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) announced today a new drug application (NDA) for the oral once-daily therapy XOSPATA® (gilteritinib), for the treatment of adult patients who have relapsed (disease that has returned) or refractory (resistant to treatment) acute myeloid leukemia (AML) with a FLT3 mutation (FLT3mut+), has been accepted by the National Medical Products Administration (NMPA) for regulatory review in China.

AML is a cancer that impacts the blood and bone marrow,1 and its incidence increases with age.2  It is estimated that every year, around 80,000 people in China are diagnosed with leukemia.3 AML is one of the most common types of leukemia in adults.4

AML patients with a FLT3 mutation have a particularly poor prognosis, with a median survival of less than six months following treatment with salvage chemotherapy.5 The status of FLT3 mutation can change over the course of AML treatment, even after relapse. As such, a patient’s mutation status should be determined to help inform the best treatment approach.6


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