EMA validates quizartinib for AMLJanuary 14, 2019
Daiichi Sankyo said the European Medicines Agency (EMA) granted accelerated assessment for quizartinib for the treatment of adults with relapsed or refractory acute myeloid leukemia (AML) which is FLT3-ITD positive.
Quizartinib is an oral selective FLT3 inhibitor currently in phase 3 development.
The EU approval was based on results of the pivotal phase 3 QuANTUM-R study of quizartinib, which was the first randomized phase 3 study to show that an FLT3 inhibitor prolonged overall survival as an oral, single agent compared to chemotherapy in patients with relapsed/refractory FLT3-ITD AML.
The median treatment duration with quizartinib was 4 cycles of 28 days each versus 1 cycle in the salvage chemotherapy arm.
Quizartinib is currently under regulatory review with the Japan Ministry of Health, Labour and Welfare (MHLW) for the treatment of adult patients with relapsed/refractory FLT3-ITD AML. Submission in the US remains on track for the second half of the fiscal year 2018.