JEMPERLI (dostarlimab-gxly) · GSK
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 Target & Pathway
ProTarget
An immune checkpoint receptor on T-cells that acts as an 'off switch' for immune responses. Cancer cells often exploit PD-1 by expressing its ligands (PD-L1/PD-L2), allowing tumors to evade immune detection. Blocking PD-1 releases this brake, enabling T-cells to recognize and attack cancer cells.
Pathway Context
PD-1 on T-cells binds to PD-L1/PD-L2 on tumor cells, suppressing immune attack
A protein expressed on tumor cells and immune cells that binds to PD-1 on T-cells, suppressing immune responses. Many cancers overexpress PD-L1 to avoid immune attack. Blocking PD-L1 prevents this immune suppression, allowing the body's T-cells to fight cancer.
A second ligand for PD-1, expressed on antigen-presenting cells and some tumors. PD-L2 binds PD-1 with higher affinity than PD-L1 but is less widely expressed. Drugs blocking PD-1 prevent both PD-L1 and PD-L2 interactions.
JEMPERLI Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in JEMPERLI's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications JEMPERLI treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to JEMPERLI
3 of 6FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
GSK's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
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
Indications & 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.