FDA approves Astellas Xospatinib for treatment in adult patients with acute myeloid leukemia

recently, Japanese drugmaker Astellas announced that the U.SFood andDrug(http://Administration (
FDA(http://) has approved Xosopa (gilteritinib) for the treatment of patients with recurrent or refractory acute myeloid leukemia (AML) in atesting(http://approved by the FDAxospataXospata is an oral therapy that makes it the first and only FLT3 targeted agent approved by the FDA for patients with recurrent or refractory AML, and marks Astellas' entry into the field of blood cancer treatment in the United StatesPrior to the, the FDA had granted Xospata orphan drug and fast-track qualification, and was granted orphan drug qualification by the Ministry of Health, Labour and Welfare (MHLW) and the European Commission (EC), and SAKIGAKE by MHLW of Japanin mid-October this year, Xospata was approved in Japan for use in adult patients with FLT3 mutation-positive recurrent or refractory AMLXospata has discovered that Astellas has exclusive global rights to develop, manufacture and potentially commercialize Xospata through research collaborations with Kotobuki Pharmaceuticals, a http:// related studies
FDA-approved Xospata is based on mid-term analysis of (http:// : Full Remission Rate (CR)/Complete Remission of Part Hematology (CRh), CR/CRh Remission Duration (DOR), Dependence on Blood Transfusion to Conversion Rate That Does Not Rely on Blood Transfusion data show that cr/CRh was 21% and the median CR/CRh was 4.6 months 56 days after the baseline period, the conversion rate from dependence on blood transfusion to non-transfusion dependence was 31.1%