TheraRadar

Pharma Intelligence, Simplified

Data updated: Mar 10, 2026

JEMPERLI

DOSTARLIMAB-GXLY Programmed Death Receptor-1-directed Antibody Interactions
Oncology Approved 2021-04-22

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-

Source: FDA Label • GSK • Programmed Death Receptor-1 Blocking Antibody
5
Indications
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Phase 3 Trials
4
Priority Reviews
4
Years on Market

Details

Status
Prescription
First Approved
2021-04-22
Routes
INJECTION
Dosage Forms
INJECTABLE

Companies

Active Ingredient: DOSTARLIMAB-GXLY

JEMPERLI Approval History

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What JEMPERLI Treats

2 indications

JEMPERLI 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
Source: FDA Label

JEMPERLI Target & Pathway

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Target

PD-1 (Programmed Cell Death Protein 1) Immune Checkpoint

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

PD-L1 (Programmed Death-Ligand 1) ligand

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.

PD-L2 (Programmed Death-Ligand 2) ligand

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 Competitors

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10 other drugs also target PD-1. Compare mechanisms, indications, and trial activity.

View all 10 PD-1 drugs →
Drug = Competitor name Company = Manufacturer N indic. = FDA-approved indications → Date = Patent/exclusivity expiry

Competitors share the same molecular target (PD-1). Earlier expiry dates signal biosimilar/generic opportunities.

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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

Full development history with FDA approval milestones

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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

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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.