First three launched oral FLT3 inhibitor Vanflyta (quizartinib) in Japan

recently, the Japanese pharmaceutical company FirstPharmaceutical(http://announced the launch of oral FLT3 inhibitor Vanflyta (quizartinib) in Japan for the treatment of recurrent/incurable FLT3-ITD acute myeloid leukemia (AML) adult patientsabout Vanflyta
Vanflyta's activedrug(http://ingredient, quizartinib, is a second-generation FLT3 inhibitor, an oral small molecule receptor tyrosine kinase inhibitor that selectively targets the inhibition of FLT3Vanflyta was approved by Japan's Ministry of Health, Labour and Welfare (MHLW) in June, the first regulatory approval of the drug worldwidethis approval, based on data from QuANTUM-R, a global lysing Phase III clinical study, and a Phase II clinical study conducted in japanese patients with recurrent/incurable FLT3-ITD AMLThe QuANTUM-R study is the first randomized Phase III study to evaluate a FLT3 inhibitor as an oral monodotherapy treatment for recurrent/difficult-treatment FLT3-ITD AML patients with recurrent/difficult treatment of AMLin this study, Vanflyta oral monotherapy significantly reduced the risk of death by 24% compared to resuscent chemotherapy (HR?0.76, p?0177, 95% CI: 0.58-0.98), significantly longer total survival (median OS: 6.2 months (bilateral test 95% CI: 5.3-7.2) vs 4.7 months (bilateral test 95% CI: 4.0-5.5) The 1-year survival rate estimated by the Vanflyta treatment group was 27% and the salvage chemotherapy group was 20%In terms of safety
the most common adverse drug reactions in patients treated with Vanflyta were nausea (33.2%, 80/241 cases), eCARDIL QT extension (24.9%, 60/241), anemia (24.9%, 60/241 cases) and platelet reduction (21.2%, 51/241 cases)Data from the Japan Phase II study show that the pre-designated primary endpoint of full mitigation rates has been reached by the time the medium-termanalysis (http:// The efficacy and safety of Vanflyta in this study were consistent with the QuANTUM-R study