Anticancer Agent "Tazverik® Tablets 200mg" (Tazemetostat Hydrobromide) Launched In Japan For EZH2 Gene Mutation-Positive Follicular Lymphoma

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) 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. (Headquarters: Massachusetts, United States)'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 Study 206,² which is a multicenter, open-label, single-arm Phase II clinical study conducted in Japan by Eisai, and other clinical studies³ conducted by Epizyme, Inc. outside of Japan.

Follicular lymphoma is a low-grade B-cell lymphoma that accounts for 10-20% of non-Hodgkin's lymphomas. Follicular lymphoma is generally indolent and sensitive to chemotherapy. However, development of a new treatment strategy is required for follicular lymphoma, which still remains difficult to cure as recurrence often occurs repeatedly. 7-27% of follicular lymphomas are reported to have gain-of-function mutations in the EZH2 gene,^4,5 and it is estimated that there are approximately 600 to 2,400 patients with follicular lymphoma with EZH2 gene mutations in Japan. A companion diagnostic test for EZH2 gene mutations, “cobas^® EZH2 Mutation Test” by Roche Diagnostics K.K. (Headquarters: Tokyo) was approved in May 2021.

For the production of this drug, Eisai is applying “Continuous Manufacturing”, an innovative pharmaceutical production technology, which was successfully developed at the Kawashima Industrial Park (Gifu Prefecture). It is the first time for Eisai to obtain a manufacturing license for Continuous Manufacturing. Continuous Manufacturing is a production method in which raw materials are continuously fed into the manufacturing process and finished products are continuously taken out. It is an advanced production technology that combines manufacturing automation and real-time quality monitoring technology. The space-saving, energy-saving system achieves high production efficiency that leads to a reduction in environmental impact, and contributes to improved quality and stable supply of pharmaceuticals.

Eisai will deliver “Tazverik” as a new treatment option for EZH2 gene mutation-positive follicular lymphoma, and will appropriately conduct a post-marketing special use results survey (all-case surveillance) in accordance with an approval condition imposed by the Ministry of Health, Labour and Welfare (MHLW) and promote the proper use of this agent.　Eisai is committed to exploring the potential clinical benefits of “Tazverik” for cancer treatment, as it seeks to contribute to addressing the diversified needs of, and increasing the benefits provided to, patients with cancer, their families and healthcare professionals.