Tazemetostat: First Approval
Tazemetostat: First Approval
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DOI：
10.1007/s40265-020-01288-x
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发表时间：
2020-04-01
期刊：
影响因子：
11.5
通讯作者：
Hoy, Sheridan M.
中科院分区：
文献类型：
--
作者：
Hoy, Sheridan M.
Tazemetostat（Tazverik（TM））是一种同类首个小分子zeste同源物2（EZH2）增强剂抑制剂，于2020年1月在美国获得加速批准，用于治疗不符合完全切除条件的局部晚期或转移性上皮样肉瘤成人和≥ 16岁青少年。由Epizyme公司与Escherai公司合作开发，它是第一种在美国被批准专门用于治疗上皮样肉瘤的疗法。推荐的剂量方案为800 mg每日两次，与或不与食物一起口服给药，直至疾病进展或出现不可接受的毒性。Tazemetostat也正在全球多个国家进行临床开发，用于其他几种肿瘤类型，包括弥漫性大B细胞淋巴瘤和间皮瘤，美国FDA接受了新药申请，并对其用于治疗滤泡性淋巴瘤给予优先审查。本文总结了tazemetostat开发的里程碑，导致首次批准用于治疗年龄≥ 16岁的成人和青少年局部晚期或转移性上皮样肉瘤，不适合完全切除。
Tazemetostat (Tazverik (TM)), a first-in-class, small molecule enhancer of zeste homolog 2 (EZH2) inhibitor, received accelerated approval in January 2020 in the USA for the treatment of adults and adolescents aged >= 16 years with locally advanced or metastatic epithelioid sarcoma not eligible for complete resection. Developed by Epizyme, in collaboration with Eisai, it is the first therapy to be approved specifically for the treatment of epithelioid sarcoma in the USA. The recommended dosage regimen is 800 mg twice daily, administered orally with or without food, until disease progression or unacceptable toxicity. Tazemetostat is also undergoing clinical development in various countries worldwide for use in several other tumour types, including diffuse large B-cell lymphoma and mesothelioma, with the US FDA accepting a New Drug Application and granting priority review for its use in the treatment of follicular lymphoma. This article summarizes the milestones in the development of tazemetostat leading to this first approval for the treatment of adults and adolescents aged >= 16 years with locally advanced or metastatic epithelioid sarcoma not eligible for complete resection.