GetHealthAccess.com | Japan: Anticancer drug “Tazverik Tablets 200mg” was approved for the treatment of follicular lymphoma caused by a mutation in the EZH2 gene | The anticancer medication EZH2 inhibitor “Tazverik Tablets 200 mg” (tazemetostat hydrobromide) was launched today by Eisai Co., Ltd. in Japan for the treatment of relapsed or refractory EZH2 gene mutation-positive follicular lymphoma (only when standard treatment is ineffective).
Follicular lymphoma is a type of low-grade B-cell lymphoma that makes up 10-20% of non-lymphomas. Hodgkin’s Follicular lymphoma is an indolent cancer that responds well to chemotherapy. Follicular lymphoma, on the other hand, requires the creation of a new therapeutic strategy because it is still difficult to cure due to recurrence. Gain-of-function mutations in the EZH2 gene have been found in 7-27 percent of follicular lymphomas,(4),(5) and it is predicted that there are between 600 to 2,400 individuals with follicular lymphoma who have EZH2 gene mutations in Japan. In May 2021, Roche Diagnostics K.K. received approval for the “cobas EZH2 Mutation Test,” a companion diagnostic test for EZH2 gene mutations.
Eisai is using “Continuous Manufacturing,” a revolutionary pharmaceutical production technique that was successfully developed at the Kawashima Industrial Park, to manufacture this medicine (Gifu Prefecture). Eisai has obtained a manufacturing license for Continuous Manufacturing for the first time. Continuous Manufacturing is a manufacturing process in which raw materials are continually fed into the process and finished products are continuously removed. It’s a cutting-edge manufacturing technique that blends factory automation with real-time quality monitoring. The space-saving, energy-saving technology delivers excellent production efficiency, which reduces environmental impact and helps to better pharmaceutical quality and supply stability.
Eisai will provide “Tazverik” as a new treatment option for follicular lymphoma patients with an EZH2 gene mutation, and will 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), as well as promote proper use of the agent. Eisai is devoted to researching the possible clinical benefits of “Tazverik” for cancer therapy in order to contribute to meeting the diverse demands of cancer patients, their families, and healthcare professionals, as well as enhancing the benefits provided to them.
1) Brand name
“Tazverik Tablets 200 mg”
2) Generic name
Tazemetostat hydrobromide
3) Indications
Relapsed or refractory EZH2 gene mutation-positive follicular lymphoma (only when standard treatment is not applicable)
4) Dosage and Administration
The usual adult dose of tazemetostat is 800mg orally twice daily. The dose may be reduced appropriately according to the condition of the patient.
5) National Health Insurance (NHI) Drug Price
Tazverik Tablets 200 mg: YEN3,004.60 (per 1 tablet)
6) Packaging
Tazverik Tablets 200 mg: 56 tablets (14 tablet PTP sheet X 4)
“Tazverik” is an oral small molecule inhibitor that targets EZH2. It is the first of its kind. Based on the March 2011 partnership agreement targeting EZH2 for research, development, and commercialization, Eisai and Epizyme, Inc. undertook joint research and development using Epizyme, Inc.’s patented product platform. To reduce methylation of H3K27, this drug selectively inhibits EZH2 in a competitive manner with S-adenosylmethionine (a methyl group donor). Eisai is responsible for the development and marketing of this agent in Japan, whereas Epizyme, Inc. is responsible for all territories outside of Japan, as a result of a change in the partnership agreement between the two businesses in March 2015.
Eisai is using Continuous Manufacturing, an innovative pharmaceutical production process that was successfully developed at the Kawashima Industrial Park, to manufacture this medicine. Eisai has obtained a manufacturing license for Continuous Manufacturing for the first time. Continuous Manufacturing is a manufacturing process in which raw materials are continually fed into the process and finished products are continuously removed. It’s a cutting-edge manufacturing technique that blends factory automation with real-time quality monitoring. The space-saving, energy-saving technology delivers excellent production efficiency, which reduces environmental impact and helps to better pharmaceutical quality and supply stability. Eisai was one of the first companies to use the Continuous Manufacturing System (CTS-MiGRA) for the production of this agent.
In the United States, this drug received accelerated approval in January 2020 for “adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma not appropriate for full resection.” In June of the same year, the FDA granted accelerated approval for this agent for the indications of “adult relapsed / refractory follicular lymphoma who have had at least 2 regimens of prior treatment and whose tumors are positive for an EZH2 mutation as detected by an FDA-approved test,” as well as “adult relapsed / refractory follicular lymphoma for which there are no satisfactory alternative treatments.”
