Daiichi Sankyo files for Japanese approval of quizartinib

17 October 2018

Daiichi Sankyo (TYO: 4568) has submitted a New Drug Application (NDA) to Japan’s Ministry of Health, Labor and Welfare (MHLW) for marketing approval of quizartinib for the treatment of adult patients with relapsed/refractory FLT3-ITD acute myeloid leukemia (AML).

The submission to Japan MHLW is based on the results of the pivotal randomized Phase III QuANTUM-R study in the USA, European Union and Asia excluding Japan, and an open-label Phase II study of quizartinib in Japan in patients with relapsed/refractory FLT3-ITD AML.

Daiichi Sankyo gained rights to quizartinib along with its $410 million acquisition of USA-based Ambit Biosciences in 2014. The drug had previously been licensed to Japan’s Astellas Pharma (TYO: 4503), which returned the rights to Ambit in 2013.

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