Association Between FDA Label Restriction and Immunotherapy and Chemotherapy Use in Bladder Cancer

JAMA. 2019 Sep 24;322(12):1209-1211. doi: 10.1001/jama.2019.10650.

Abstract

This research letter discusses the association between label restrictions by the US Food and Drug Administration on first-line immunotherapy for advanced bladder cancer and subsequent changes in practice.

Publication types

  • Research Support, N.I.H., Extramural

MeSH terms

  • Aged
  • Antibodies, Monoclonal / therapeutic use
  • Antibodies, Monoclonal, Humanized / therapeutic use
  • Antineoplastic Agents / therapeutic use*
  • Cisplatin / therapeutic use
  • Drug Labeling / legislation & jurisprudence*
  • Drug Therapy / trends*
  • Female
  • Government Regulation
  • Humans
  • Immunotherapy / trends*
  • Logistic Models
  • Male
  • Product Surveillance, Postmarketing
  • Programmed Cell Death 1 Receptor / antagonists & inhibitors*
  • United States
  • United States Food and Drug Administration
  • Urinary Bladder Neoplasms / drug therapy*
  • Urinary Bladder Neoplasms / therapy

Substances

  • Antibodies, Monoclonal
  • Antibodies, Monoclonal, Humanized
  • Antineoplastic Agents
  • Programmed Cell Death 1 Receptor
  • atezolizumab
  • pembrolizumab
  • Cisplatin