Astellas releases DATA from PHASE III ADMIRAL, a targeted cancer drug, xospatinib

recently, Japanese drugmaker Astellas released data from the phase III ADMIRAL study (NCT02421939), a targeted cancer drugAbout XospataXospata is a second-generation FLT3 inhibitor, and 2 different mutations are inhibited for FLT3 cross-membrane internal series repeat (ITD) and FLT3 tyrosine kinase domain (TKD)FLT3-ITD mutations affect about 30% of AML patients and are associated with worsening disease-free survival and overall survivalFLT3-TKD mutation affects about 7% of AML patientsAlthough the effects of these mutations are not yet clear, they are associated with treatment of drug resistanceThe studyan open label, multicenter, randomized Phase III study that compared Xospata with resuscent chemotherapy for adult patients with FLT3 mutation acute myeloid leukemia (AML) who had difficult treatment or relapsed after treatmentThe primary endpoint ofresearch is total lifetime (OS)The study enrolled a total of 371 patients with recurrent or refractory AML, positive for FLT3 mutation in bone marrow or whole bloodIn the study, patients were randomly assigned to Xospata (120 mg) or salvage chemotherapy at a 2:1 ratioThe results showed that the XOspata treatment group showed a significant lynautopsy of OS compared to the standard salvage chemotherapy groupThe specific data were: 9.3 months in the Xospata treatment group and 5.6 months in the rescue chemotherapy group (HR:0.637, 95% CI: 0.490-0.830, p-0.007);In Japan and the United States, Xospata was approved in September and November 2018 for the treatment of adult patients with a recurrence or incurable AML of FLT3 mutations confirmed by theFDA(http:// approved testing (http:// In the European Union, The Xospata listing permit application was accepted by the European Medicines (http:// Authority (EMA) in February 2019 　　Currently, Astellas is conducting several Phase III studies to assess the efficacy and safety of Xospata in several different GROUPS of FLT3 mutation-positive AML patients Xospata has discovered that Astellas has exclusive global rights to develop, manufacture and commercialize Xospata through research collaborations with Kotobuki Pharmaceuticals, a http:// , Japan