Eisai launches Tazverik in Japan to treat EZH2 mutation-positive FL

Eisai recently announced that it has launched the anticancer drug Tazverik in the Japanese market.

Eisai recently announced that it has launched the anticancer drug Tazverik (tazemetostat, 200mg tablet) in the Japanese market.

The active pharmaceutical ingredient of Tazverik is tazemetostat, which is an oral, pioneering EZH2 small molecule inhibitor, created using Epizyme's proprietary product platform

In Japan, Tazverik was approved in June 2021

The results showed that the Study 206 study reached the primary endpoint and exceeded the pre-set tumor remission threshold, which is statistically significant: through the independent review committee (IRC) evaluation results, EZH2 mutation-positive relapsed or refractory FL patients (n =17) The overall response rate (ORR) was 76.

Eisai will conduct a post-marketing special result survey (monitoring of all cases) on all patients taking Tazverik until the predetermined number of patients is reached according to the approval conditions stipulated by the MHLW

Follicular lymphoma (FL) is a low-grade B-cell lymphoma that accounts for 10-20% of non-Hodgkin's lymphoma (NHL)

tazemetostat is an oral, potent, pioneering, EZH2 inhibitor

In the United States, tazemetostat (trade name: Tazverik) received accelerated FDA approval in January 2020 for the treatment of pediatric and adult patients with metastatic or locally advanced epithelioid sarcoma (ES) who are 16 years and older and do not meet the conditions for complete resection

In June 2020, tazemetostat received accelerated approval from the US FDA for the treatment of 2 different FL indications: (1) The tumor was confirmed to be positive for EZH2 mutation by the FDA-approved test method and had previously received at least 2 systemic therapies.

Currently, tazemetostat is being developed for many types of hematological malignancies (non-Hodgkin’s lymphoma: relapsed or refractory diffuse large B-cell lymphoma [DLBCL], follicular lymphoma [FL]) And genetically defined solid tumors (epithelioid sarcoma, synovial sarcoma, INI1-negative tumors, castration-resistant prostate cancer, platinum-resistant solid tumors, etc.

Original source: Anticancer Agent "Tazverik Tablets 200mg" (Tazemetostat Hydrobromide) Launched in Japan for EZH2 Gene Mutation-Positive Follicular Lymphoma