TEVIMBRA
TEVIMBRA (tislelizumab-jsgr) is a programmed death receptor-1 (PD-1)-blocking antibody indicated for the treatment of specific gastrointestinal cancers, including esophageal squamous cell carcinoma (ESCC) and gastric or gastroesophageal junction (G/GEJ) adenocarcinoma. It is used as a first-line treatment in combination with chemotherapy for patients with unresectable or metastatic disease whose tumors express PD-L1. Additionally, the drug is approved as a monotherapy for adults with previously treated ESCC who have not received a prior PD-(L)1 inhibitor.
How TEVIMBRA Works
Tislelizumab-jsgr binds to the PD-1 receptor on T cells to block its interaction with the ligands PD-L1 and PD-L2. Normally, when these ligands bind to PD-1, they inhibit T-cell proliferation and cytokine production, which can allow tumors to evade the immune system. By blocking this pathway, the drug releases the inhibition of the immune response and restores the body’s anti-tumor activity.
Details
- Status
- Prescription
- First Approved
- 2024-03-13
- Routes
- SOLUTION, INTRAVENOUS, INJECTION
- Dosage Forms
- INJECTION, INJECTABLE
TEVIMBRA Approval History
What TEVIMBRA Treats
4 indicationsTEVIMBRA is approved for 4 conditions since its original approval in 2024. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Esophageal Cancer
- Esophageal Squamous Cell Carcinoma
- Gastric Cancer
- Gastroesophageal Junction Adenocarcinoma
TEVIMBRA 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.
TEVIMBRA 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.
TEVIMBRA FDA Label Details
ProIndications & Usage
FDA Label (PDF)TEVIMBRA is a programmed death receptor-1 (PD-1)-blocking antibody indicated for: Esophageal Cancer in combination with platinum-containing chemotherapy for the first-line treatment of adults with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) whose tumors express PD-L1 (≥1). as a single agent in adults with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) after prior systemic chemotherapy that did not include a PD-(L)1 inhibitor. Gastric Cancer in combination with platinum and fluoropyrimidine-based chemotherapy in adults for the first line treatment ...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.