Jemperli FDA Approval History
Last updated by Judith Stewart, BPharm on Sep 1, 2021.
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.
- 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
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.