EMA accepts first triple-targeted cancer drug quizartinib for listing license for AML adult patients

AML is an invasive blood and bone marrow cancer that causes abnormally dysfunctional cancerous white blood cells in the patient's body to grow and accumulate uncontrolledly and affect the production of normal blood cellsrecently, the Japanese pharmaceutical company First threePharmaceutical(announced that the EuropeanDrug(EMA) has accepted the target anti-cancer drug quizartinib treatment recurrent/incurable FLT3-ITD acute myeloid leukemia (AML) adult patients market license application (MAA) and granted accelerated evaluation eligibilityTHE EMA HUMAN
MEDICINE
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(CHMP) WILL BEGIN A SCIENTIFIC REVIEW OF THE MAA OF QUIZARTINIBThe accelerated assessment of eligibility means that the formal review time for quizartinib in the EU will be shortened by 60 daysabout quizartinib
quizartinib is an oral small molecule receptor tyrosine kinase inhibitor that selectively targets the suppression of FLT3In the United States, quizartinib has been awarded theFDA(granted breakthroughdrug(qualifying, treatment of recurrent/refractory AML) in adult patients with recurrent/incurable AMLin addition, quizartinib has been awarded the orphan drug for the treatment of AML in the United States and the European Union, and the orphan drug for the treatment of FLT3 mutation AML in Japancurrently, quizartinib treats recurrent/incurable FLT3-ITD AML adult patients withnew drug(application sits also under accelerated review by the Ministry of Health, Labour and Welfare (MHLW)For its part, the first three are scheduled to be submitted in the second half of fiscal 2018related studiesthe submission of the quizartinib MAA is based on data from the key Phase III clinical study QuANTUM-Rit is worth noting that this 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/incurable FLTD AMLin this study, the oral monotherapy of quizartinib 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 quizartinib treatment group was 27%, and the salvage chemotherapy group was 20%