JEMPERLI
JEMPERLI (dostarlimab-gxly) is a programmed death receptor-1 (PD-1)–blocking antibody indicated for the treatment of adult patients with endometrial cancer and certain solid tumors. It is used in combination with chemotherapy for primary advanced or recurrent endometrial cancer, or as a single agent for mismatch repair deficient (dMMR) cases that have progressed after platinum-
Details
- Status
- Prescription
- First Approved
- 2021-04-22
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
JEMPERLI Approval History
What JEMPERLI Treats
2 indicationsJEMPERLI is approved for 2 conditions since its original approval in 2021. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Endometrial Cancer
- Solid Tumors
JEMPERLI Competitors
Pro10 other drugs also target PD-1. Compare mechanisms, indications, and trial activity.
Competitors share the same molecular target (PD-1). Earlier expiry dates signal biosimilar/generic opportunities.
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Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
JEMPERLI FDA Label Details
ProIndications & Usage
FDA Label (PDF)JEMPERLI is a programmed death receptor-1 (PD-1)–blocking antibody indicated: Endometrial Cancer • in combination with carboplatin and paclitaxel, followed by JEMPERLI as a single agent, for the treatment of adult patients with primary advanced or recurrent endometrial cancer (EC). • as a single agent for the treatment of adult patients with mismatch repair deficient (dMMR) recurrent or advanced EC, as determined by an FDA-approved test, that has progressed on or following prior treatment with a platinum-containing regimen in any setting and are not candidates for curative surgery or radiation...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.