Daiichi Sankyo submits NDA for Lymphoma treatment Valemetostat in Japan

Tokyo: Daiichi Sankyo Company, Limited has announced that it has submitted a New Drug Application (NDA) to Japan's Ministry of Health, Labour and Welfare (MHLW) for valemetostat, a potential first-in-class dual inhibitor of EZH1 and EZH2, for the treatment of patients with relapsed/refractory adult T-cell leukemia/lymphoma (ATL).

ATL is a rare and aggressive type of peripheral T-cell lymphoma that occurs with greater frequency in parts of Japan and other regions. Patients with ATL face a poor prognosis with current therapies. Nearly 90% of patients relapse after completing intensive first-line treatment, at which point there are few optionsavailable.

The Japan NDA submission of valemetostat is based on pivotal phase 2 study results in Japanese patients with three aggressive subtypes of relapsed/refractory ATL, recently presented at the 2021 American Society of Hematology (ASH) Annual Meeting. Valemetostat previously received Orphan Drug designation (ODD) from the Japan MHLW for treatment of patients with relapsed/refractory ATL.

"Valemetostat would potentially be the first dual inhibitor of EZH1 and EZH2 to be approved anywhere in the world and could provide a new type of targeted therapy option for patients with relapsed/refractory ATL, which represents one of the most significant unmet medical needs in Japan," said Wataru Takasaki, PhD, Executive Officer, Head of R&D Division in Japan, Daiichi Sankyo. "Valemetostat is the fifth innovative oncology medicine from our pipeline to be submitted for regulatory approval in Japan in the past three years."