癌症免疫疗法更新：FDA 批准的检查点抑制剂和伴随诊断。
Cancer Immunotherapy Update: FDA-Approved Checkpoint Inhibitors and Companion Diagnostics.
机构信息
Office of Biotechnology Products, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, 20993, USA.
出版信息
AAPS J. 2021 Mar 7;23(2):39. doi: 10.1208/s12248-021-00574-0.
Immune checkpoint inhibitors (ICIs) are considered a new standard-of-care across many cancer indications. This review provides an update on ICIs approved by the Food and Drug Administration (FDA), with focus on monoclonal antibodies that target the programmed cell death 1 (PD-1) or its ligand, PD-1 ligand 1 (PD-L1), including information on their clinical indications and associated companion diagnostics. The information is further discussed with strategies for identifying predictive biomarkers to guide the clinical use of PD-1/PD-L1-targeted therapies.
免疫检查点抑制剂（ICIs）被认为是许多癌症适应证的新标准治疗方法。本综述提供了食品和药物管理局（FDA）批准的 ICI 的最新信息，重点介绍了针对程序性细胞死亡 1（PD-1）或其配体 PD-1 配体 1（PD-L1）的单克隆抗体，包括其临床适应证和相关伴随诊断信息。进一步讨论了识别预测生物标志物的策略，以指导 PD-1/PD-L1 靶向治疗的临床应用。
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