EMA validates quizartinib for AML

January 14, 2019 0 By FM

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.