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Jemperli FDA Approval History

Last updated by Judith Stewart, BPharm on Sep 1, 2021.

FDA Approved: Yes (First approved April 22, 2021)
Brand name: Jemperli
Generic name: dostarlimab-gxly
Dosage form: Injection
Company: GlaxoSmithKline
Treatment for: Endometrial Cancer, Solid Tumors

Jemperli (dostarlimab-gxly) is a programmed death receptor-1 (PD-1)–blocking antibody for the treatment of mismatch repair deficient (dMMR) endometrial cancer, and dMMR solid tumors.

  • Jemperli is indicated for the treatment of adult patients with mismatch repair deficient (dMMR) recurrent or advanced:
    • endometrial cancer, as determined by an FDA-approved test, that has progressed on or following prior treatment with a platinum-containing regimen, or
    • solid tumors, as determined by an FDA-approved test, that have progressed on or following prior treatment and who have no satisfactory alternative treatment options.
    1. These indications are approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
  • Jemperli is administered as an intravenous infusion over 30 minutes every three weeks for the first four doses, then every six weeks from dose 5 onwards.
  • Common adverse reactions include fatigue/asthenia, nausea, diarrhea, anemia, and constipation.

Development Timeline for Jemperli

DateArticle
Aug 17, 2021Approval  GSK Receives FDA Accelerated Approval for Jemperli (dostarlimab-gxly) for Adult Patients with Mismatch Repair-Deficient (dMMR) Recurrent or Advanced Solid Tumors
Apr 22, 2021Approval  FDA Approves Jemperli (dostarlimab-gxly) for Women with Recurrent or Advanced dMMR Endometrial Cancer
Jan 16, 2021GSK Presents Positive Efficacy Data of Dostarlimab in Mismatch Repair-Deficient (dMMR) Solid Cancers at ASCO Gastrointestinal Cancers Symposium
Apr 28, 2020GSK Presents New Data from the GARNET Study Demonstrating Potential of Dostarlimab to Treat a Subset of Women with Recurrent or Advanced Endometrial Cancer
Mar 19, 2019Data From GARNET Study Indicates Robust Activity of Dostarlimab in Patients with Advanced or Recurrent Endometrial Cancer

Further information

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