FDA grants Astex pharmaceutical anti-cancer drug ASTX727 orphan drug

recently, Japanese pharmaceutical company OtsukaPharmaceuticals(http://wholly-owned sub-
company(http://Astex Pharmaceuticals announced that the U.SFood andDrug(http://Administration (
FDA(http://) has granted the company the company's oral fixed-dose combination anti-cancer drug ASTX727 orphan drug for the treatment of bone marrow hyperplasia syndrome (MDS), including chronic myeloid leukemia (CMML)About ASTX727
ASTX727 is a new oral combination therapy consisting of a fixed dose of cedazuridine (a cytoside deaminase inhibitor) and disitribin (an approved anti-cancer DNA demethylator) 　　Among them, cedazuridine components can inhibit the intestinal and liver cytoside deaminase, to avoid degradation of the west of the west, so that ASTX727 can achieve oral administration of the west of the west, to achieve the same exposure equivalent as the dissytadeain intravenous infusion 　　In June 2019, Otsuka and Astex published the top line results of the ASTX727 III ASCERTAIN study The study, conducted in 138 patients with bone marrow hyperplasia syndrome (MDS) and chronic myeloid mononucleosis leukemia (CMML) who had not been treated (initial treatment) and treated (treated) in 138 patients, assessed the efficacy and safety of ASTX727 and decitabine IV intravenous infusions (decitabine IV) 　　The results showed that oral ASTX727 had the same exposure equivalent as the intravenous infusion of the West Tambin program, reaching the main end of the study 　　According to the study, Astex plans to submit a new drug (http:// application (NDA) to the FDA in 2019