Dostarlimab: First Approval

Drugs. 2021 Jul;81(10):1213-1219. doi: 10.1007/s40265-021-01539-5.


Dostarlimab (Jemperli™; GlaxoSmithKline) is a humanized monoclonal antibody programmed death-1 (PD-1) receptor antagonist being developed for the treatment of various cancers. Based on preliminary results from the GARNET trial dostarlimab has recently been approved in the EU and USA for the treatment of adult patients with mismatch repair deficient recurrent or advanced endometrial cancer. This article summarizes the milestones in the development of dostarlimab leading to these first approvals.

Publication types

  • Review

MeSH terms

  • Antibodies, Monoclonal, Humanized / adverse effects
  • Antibodies, Monoclonal, Humanized / pharmacology
  • Antibodies, Monoclonal, Humanized / therapeutic use*
  • Antineoplastic Agents, Immunological / adverse effects
  • Antineoplastic Agents, Immunological / pharmacology
  • Antineoplastic Agents, Immunological / therapeutic use*
  • Clinical Trials as Topic
  • Drug Approval
  • Endometrial Neoplasms / drug therapy*
  • Europe
  • Female
  • Humans
  • Neoplasms / drug therapy
  • Programmed Cell Death 1 Receptor / antagonists & inhibitors*
  • United States
  • United States Food and Drug Administration


  • Antibodies, Monoclonal, Humanized
  • Antineoplastic Agents, Immunological
  • Programmed Cell Death 1 Receptor
  • dostarlimab