Cancer Immunotherapy Update: FDA-Approved Checkpoint Inhibitors and Companion Diagnostics

被引：477

作者：

Twomey, Julianne D. ^{[1
]}

Zhang, Baolin ^{[1
]}

机构：

[1] US FDA, Off Biotechnol Prod, Ctr Drug Evaluat & Res, Silver Spring, MD 20993 USA

来源：

AAPS JOURNAL | 2021年 / 23卷 / 02期

关键词：

cancer immunotherapy; immune checkpoint inhibitor; biomarker; companion diagnostic; METASTATIC UROTHELIAL CARCINOMA; CISPLATIN-INELIGIBLE PATIENTS; NIVOLUMAB PLUS IPILIMUMAB; TUMOR MUTATIONAL BURDEN; SINGLE-ARM; OPEN-LABEL; PREDICTIVE BIOMARKER; 1ST-LINE TREATMENT; PD-L1; EXPRESSION; DOUBLE-BLIND;

D O I：

10.1208/s12248-021-00574-0

中图分类号：

R9 [药学];

学科分类号：

1007 ;

摘要：

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.

引用

页数：11

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