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

AAPS J. 2021 Mar 7;23(2):39. doi: 10.1208/s12248-021-00574-0.

Abstract

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.

Keywords: biomarker; cancer immunotherapy; companion diagnostic; immune checkpoint inhibitor.

Publication types

  • Research Support, U.S. Gov't, P.H.S.
  • Review

MeSH terms

  • B7-H1 Antigen / antagonists & inhibitors
  • Biomarkers, Tumor / analysis*
  • Clinical Decision-Making / methods
  • Diagnostic Test Approval / legislation & jurisprudence
  • Drug Approval / legislation & jurisprudence
  • Drug Approval / statistics & numerical data
  • Humans
  • Immune Checkpoint Inhibitors / pharmacology
  • Immune Checkpoint Inhibitors / therapeutic use*
  • Neoplasms / diagnosis
  • Neoplasms / drug therapy*
  • Neoplasms / immunology
  • Programmed Cell Death 1 Receptor / antagonists & inhibitors
  • Reagent Kits, Diagnostic*
  • United States
  • United States Food and Drug Administration / legislation & jurisprudence*
  • United States Food and Drug Administration / statistics & numerical data

Substances

  • B7-H1 Antigen
  • Biomarkers, Tumor
  • CD274 protein, human
  • Immune Checkpoint Inhibitors
  • PDCD1 protein, human
  • Programmed Cell Death 1 Receptor
  • Reagent Kits, Diagnostic

Grants and funding