Eisai Co., Ltd. has submitted a marketing authorization application in Japan for the EZH2 inhibitor tazemetostat hydrobromide for EZH2 gene mutation-positive follicular lymphoma.

Eisai Co., Ltd. has announced that it has submitted a marketing authorization application in Japan for the EZH2 inhibitor tazemetostat hydrobromide (generic name, development code: E7438, “tazemetostat”) for EZH2 gene mutation-positive follicular lymphoma.

This application is based on the results of a multicenter, open-label, single-arm clinical phase II trial (Study 206) in Japan conducted by Eisai and other studies conducted by Epizyme, Inc. outside Japan. Study 206 enrolled patients with EZH2 gene mutation positive, primarily follicular lymphoma which had relapsed or was refractory. The primary endpoint of this study was objective response rate, and secondary endpoints included safety. Detailed results of the study will be presented at upcoming academic conferences.

Tazemetostat is a first-in-class, oral EZH2 inhibitor discovered by Epizyme, Inc. This agent is known to selectively inhibit EZH2, an epigenetic enzyme which belongs to the histone methyltransferase family and may have an important role in carcinogenesis. This results in the control of expression of various cancer related genes, leading to the suppression of proliferation of cancer cells. Eisai is responsible for development and commercialization of tazemetostat in Japan, while Epizyme, Inc. is responsible for all regions outside Japan. In June, tazemetostat received accelerated approval for follicular lymphoma in the United States.