TOKYO, Aug 16, 2021 - (JCN Newswire via SEAPRWire.com) - Eisai Co., Ltd. announced today that it has launched the anticancer agent EZH2 inhibitor "Tazverik Tablets 200 mg" (tazemetostat hydrobromide), in Japan with the indication of relapsed or refractory EZH2 gene mutation-positive follicular lymphoma (only when standard treatment is not applicable). Eisai obtained the manufacturing and marketing approval of "Tazverik" on June 23, 2021. "Tazverik" was included to Japan's National Health Insurance Drug Price List on August 12, 2021.Created by utilizing Epizyme, Inc.'s proprietary product platform, "Tazverik" is a first-in-class small molecule inhibitor of the epigenetic enzyme EZH2. It is one of the histone methyltransferases in the epigenetics-related protein group, and is thought to regulate the expression of cancer-related genes and suppress the growth of cancer cells by specifically targeting EZH2, which contributes to the cancer growth process.(1) Eisai is responsible for the development and commercialization of this agent in Japan, while Epizyme, Inc. is responsible for all regions outside of Japan. The approval of "Tazverik" in Japan is based on data including results from S...

TOKYO, Jun 23, 2021 - (JCN Newswire via SEAPRWire.com) - Eisai Co., Ltd. announced today that it has obtained manufacturing and marketing approval for the EZH2 inhibitor "Tazverik Tablets 200 mg" (tazemetostat hydrobromide) in Japan with the indication of relapsed or refractory EZH2 gene mutation-positive follicular lymphoma (only when standard treatment is not applicable).This approval is based on the results of a multicenter, open-label, single-arm clinical phase II trial (Study 206)(1) in Japan conducted by Eisai and other studies(2) conducted by Epizyme, Inc. (Headquarters: Massachusetts, United States) outside Japan. Study 206 enrolled patients with EZH2 gene mutation- positive, primarily follicular lymphoma, who had relapsed or were refractory. The primary endpoint of this study was objective response rate (ORR), and secondary endpoints included safety. This study achieved the primary endpoint target and exceeded a prespecified tumor response threshold with statistical significance: ORR in patients with EZH2 mutation-positive relapsed or refractory follicular lymphoma (n=17) was 76.5% (90% confidence interval (CI): 53.9-91.5) as measured by independent review.Treatment-emerge...