Sintilimab: First Global Approval
Sintilimab: First Global Approval
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DOI：
10.1007/s40265-019-1066-z
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发表时间：
2019-02-01
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.
Sintilimab（Tyvyt（（R）是一种完全人源性IgG 4单克隆抗体，可与程序性细胞死亡受体-1（PD-1）结合，从而阻断PD-1与其配体（PD-L1和PL-L2）的相互作用，从而帮助恢复内源性抗肿瘤T细胞应答。它由Innovent Biologics和Eli Lilly and Company共同开发，最近在中国获批用于治疗2线全身化疗后复发或难治的经典霍奇金淋巴瘤患者。Sintiliumab正在中国进行I、II和III期开发，用于治疗各种实体瘤，包括非小细胞肺癌和食管癌。用于实体瘤的sintilimab的I/II期开发正在美国进行，美国FDA于2018年1月接受了sintilimab的研究性新药申请。本文总结了sintiliumab开发的里程碑，导致首次批准用于治疗2线全身化疗后复发或难治的经典霍奇金淋巴瘤患者。
Sintilimab (Tyvyt((R))) is a fully human IgG4 monoclonal antibody that binds to programmed cell death receptor-1 (PD-1), thereby blocking the interaction of PD-1 with its ligands (PD-L1 and PL-L2) and consequently helping to restore the endogenous antitumour T-cell response. It has been co-developed by Innovent Biologics and Eli Lilly and Company, and was recently approved in China for the treatment of classical Hodgkin's lymphoma in patients who have relapsed or are refractory after2 lines of systemic chemotherapy. Sintilimab is undergoing phase I, II and III development for use in various solid tumours, including non-small cell lung cancer and oesophageal cancer, in China. Phase I/II development of sintilimab for use in solid tumours is underway in the USA, with the US FDA accepting an Investigational New Drug application for sintilimab in January 2018. This article summarizes the milestones in the development of sintilimab leading to this first approval for the treatment of classical Hodgkin's lymphoma in patients who have relapsed or are refractory after2 lines of systemic chemotherapy.