Japan-based Daiichi Sankyo Company Limited announced yesterday that it 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 leukaemia (AML).

The submission to Japan MHLW is based on the results of the pivotal randomised phase 3 QuANTUM-R study in the US, EU and Asia excluding Japan, and an open-label phase 2 study of quizartinib in Japan in patients with relapsed/refractory FLT3-ITD AML.

Kouichi Akahane, PhD, MBA, executive officer, head of Oncology Function, R&D Division, Daiichi Sankyo, said, 'Quizartinib has been designed as a specific inhibitor of FLT3 with high affinity for FLT3-ITD, a driver mutation in AML that is linked to poor prognosis and is associated with aggressive disease that results in increased relapse rate and reduced overall survival for patients compared to those without this mutation. We look forward to working closely with the Japan Health Authority on our application for quizartinib in order to bring this important potential new targeted treatment option to patients with relapsed/refractory FLT3-ITD AML in Japan.'

Quizartinib is the first FLT3 inhibitor to prolong overall survival as an oral, single agent compared to chemotherapy in patients with relapsed/refractory FLT3-ITD AML. This was demonstrated in a randomized phase 3 trial (QuANTUM-R) and top-line results of QuANTUM-R were presented during the plenary program at the 23rd Congress of the European Hematology Association in June 2018.