Astellas announces its FLT3 inhibitor XOSPATA for leukemia and is under regulatory review at NMPA
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Last Update: 2020-06-24
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Source: Internet
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Author: User
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Astellas Pharmaceuticals (Astellas) has announced that XOSPATA (gilteritinib) new drug application (NDA) for the treatment of adult patients with acute myeloid leukemia (AML) with FLT3 mutation, recurrence or incurability is under regulatory review by the State Food and Drug Administration of China (NMPA)The incidence of AML increases with age, and it is estimated that about 80,000 people in China are diagnosed with leukemia each yearAML is one of the most common types of leukemia in adultsAML patients with FLT3 mutation had a particularly poor prognosis, with a median survival of less than six months after treatment with therapeutic lysisGilteritinib is a second-generation FLT3 inhibitor that inhibits flT3 interstitulated repetition (ITD) and FLT3 tyrosine kinase domain (TKD), two common types of FLT3 mutations, accounting for approximately one-third of all AML casesIn addition, the drug also shows the inhibitory effect on AXLGilteritinib has been granted orphan medicine and fast-track designation by the U.SFDA, and orphan drug status in the European Union and Japan
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