(Lymphoma) Eisai Begins Selling EZH2 Inhibitor Tazverik 200mg in Japan
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Tazverik Launched in Japan for EZH2-Mutant Follicular Lymphoma
- August 18, 2021
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On August 16, 2021, Eisai announced the commercial launch in Japan of Tazverik (tazemetostat) 200mg — an EZH2 inhibitor anticancer drug for follicular lymphoma — approved for relapsed/refractory patients with EZH2 gene mutation-positive disease who are not eligible for standard treatment.
Mechanism of Action
Tazverik is an orally administered EZH2 inhibitor that selectively suppresses EZH2 (a histone methyltransferase involved in carcinogenesis), thereby modulating cancer-related gene expression and inhibiting cancer cell growth. Tazverik received manufacturing and marketing approval in June 2021.
Basis for Approval
The marketing authorization was based on results from a domestic Phase 2 trial in Japan (Study 206) and overseas clinical trials. Study 206 was an open-label, single-arm, multicenter trial in patients with previously treated, relapsed/refractory EZH2 mutation-positive follicular lymphoma (N=17). The primary endpoint objective response rate was 76.5%, significantly exceeding the predefined threshold.
Statement from Eisai
In their press release, Eisai stated that they aim to provide Tazverik as a new treatment option for EZH2 mutation-positive follicular lymphoma, conduct post-marketing surveillance appropriately under the approval conditions, and contribute to meeting the diverse needs of cancer patients, their families, and healthcare professionals through this drug.
Source: https://www.eisai.co.jp/news/2021/news202170.html
- Clinical trial drug
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