New drug for leukemia! Astellas second-generation FLT3 inhibitor Xospata has been approved by the FDA to treat relapse/difficulty:

The U.S. Food and Drug Administration (FDA) has approved Xospata (gilteritinib) for the treatment of adult patients with recurring or refractic (drug-resistant) acute myeloid leukemia (AML) with FLT3 mutations, the Japanese drug company Astellas announced recently. Xospata is an oral therapy that has been approved to make it the first and only FLT3 targeted drug approved by the FDA for recurring or refractic AML patient populations, and also marks Astellas' entry into the U.S. blood cancer treatment field.
the American Cancer Society estimates that about 19,000 people in the United States will be diagnosed with AML in 2018. AML is associated with a variety of gene mutations. Xospata is a second-generation FLT3 inhibitor that inhibits two different mutations, FLT3 in-line repetition (ITD) and FLT3 tyrosine kinase domain (TKD). The FLT3-ITD mutation affects about 30% of AML patients and is associated with worsening disease-free survival and overall survival. The FLT3-TKD mutation affects about 7% of AML patients. Although the effects of these mutations are not yet clear, they are associated with therapeutic resistance.
, the FDA has granted Xospata orphan drug eligibility and fast-track qualification, and the Ministry of Health, Labour and Welfare (MHLW) and the European Commission (EC) of Japan, and SAKIGAKE by Japan's MHLW. In mid-October, Xospata was approved by Japan for use in adult patients with FLT3 mutation-positive recurring or incurable AML.
Xospata found that Astellas has exclusive global rights to develop, manufacture and potentially commercialize Xospata through research with Kotobuki Pharmaceuticals of Japan.
FDA approval of Xospata is based on an interim analysis of the following endpoints in ADMIRAL clinical studies: Full Remission Rate (CR)/Complete Remission (CRh), CR/CRh Remission Duration (DOR), conversion rate dependent on blood transfusion to non-dependent blood transfusion. The data show that CR/CRh is 21% and CR/CRh has a medium DOR of 4.6 months. The conversion rate from dependence on blood transfusions to non-dependence on blood transfusions was 31.1 per cent 56 days after the baseline period.
results from the ADMIRAL study will be presented at an upcoming medical conference.
noted that in April 2017, Novartis' targeted cancer drug, Midostaurin, was approved by the FDA to treat new AML-positive patients with FLT3 mutations. The approval makes Rydapt the world's first targeted drug for the first-line treatment of FLT3 mutation-positive AML. (Bio Valley)