New drug for leukemia! The first three total FLT3 inhibitors quizartinib were evaluated by the EU EMA accelerated

Daiichi Sankyo, a Japanese pharmaceutical company, recently announced that the European Medicines Agency (EMA) has accepted the application for a listing permit (MAA) for adult patients with the targeted cancer drug quizartinib to treat recurring/refractic FLT3-ITD acute myeloid leukemia (AML). The EMA Human Pharmaceutical Products Committee (CHMP) will begin a scientific review of quizartinib's MAA. The accelerated assessment of eligibility means that quizartinib's formal review time in the EU will be reduced by 60 days.
quizartinib MAA is based on data from Quantum-R, a critical Phase III clinical study. It is worth mentioning that this study is the first random Phase III study to evaluate a FLT3 inhibitor as an oral monotherapy relative to chemotherapy therapy recurrence/refractic FLT3-ITD AML patients significantly extending total survival. In this study, quizartinib oral monotherapy significantly reduced the risk of death by 24% (HR=0.76, p=0.0177,95% CI:0.58-0.98) and significantly longer total lifetime (mesoOS: 6.2 months (bilateral test 95% CI: 5.3-7.2) vs 4.7 months (bilateral test 95% CI: 4.0-5.5));Arnaud Lesegretain, vice president of oncology research at
First Third, said the EMA's award of quizartinib accelerated assessment qualification highlights the significant unsecured medical needs in the recurring/refractic FLT3-ITD AML patient population, a highly invasive disease that has not yet been approved for targeted treatment in Europe. We look forward to working with EMA to bring this important and potentially new targeted treatment to patients in Europe.
, quizartinib's application for new drugs for the treatment of recurring/refractic FLT3-ITD AML adult patients is also under accelerated review by the Ministry of Health, Labour and Welfare (MHLW). For the U.S. side, the first three are scheduled to be submitted in the second half of fiscal 2018.
AML is an invasive blood and bone marrow cancer that causes uncontrolled growth and accumulation of abnormally functioning cancerous white blood cells in the patient's body and affects the production of normal blood cells. FLT3 gene mutations are one of the most common genetic abnormalities in AML, where FLT3-ITD is the most common FLT3 mutation, affecting about a 1/4 of AML patients. FLT3-ITD is a driving mutation with high leukemia burden, poor prognosticity and significant impact on disease management in AML patients. The overall prognosis of FLT3-ITD AML patients was worse than in AML patients who did not carry FLT3-ITD mutations, including an increased recurrence rate, an increased risk of death after recurrence, and a higher likelihood of recurrence after hematopoietic stem cell transplantation.
quizartinib is an oral small molecule subject tyrosine kinase inhibitor that selectively targets FLT3. In the United States, quizartinib has been awarded the FDA's breakthrough drug qualification for the treatment of recurring/refragsive FLT3-ITD AML adult patients, as well as fast-track status for the treatment of recurring/refragsive AML. In addition, quizartinib has been granted the treatment of AML orphan drugs in the United States and the European Union, and in Japan has been granted the treatment of FLT3 mutation AML orphan drug qualification. (Bio Valley)