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Tevimbra (TISLELIZUMAB)
Tevimbra blocks the PD-1 receptor, allowing the immune system to recognize and attack cancer cells.
Tevimbra (tislelizumab) is a monoclonal antibody developed by Beigene that targets the PD-1 receptor, a protein that helps cancer cells evade the immune system. It works by blocking the PD-1 receptor, allowing the immune system to recognize and attack cancer cells. Tevimbra is approved to treat various types of esophageal and gastric cancers, including unresectable or metastatic esophageal squamous cell carcinoma and unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma. Tevimbra is a patented product owned by Beigene, with no generic manufacturers listed. Key safety considerations include potential immune-mediated adverse reactions.
At a glance
| Generic name | TISLELIZUMAB |
|---|---|
| Sponsor | Beigene |
| Drug class | Programmed Death Receptor-1 Blocking Antibody [EPC] |
| Target | Pd-1 |
| Modality | Monoclonal antibody |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
| First approval | 2025 |
| Annual revenue | 900 |
Mechanism of action
Binding of the PD-1 ligands PD-L1 and PD-L2, to the PD-1 receptor found on T cells, inhibits T-cell proliferation and cytokine production. Upregulation of PD-1 ligands occurs in some tumors and signaling through this pathway can contribute to inhibition of active T-cell immune surveillance of tumors. Tislelizumab-jsgr binds to PD-1 and blocks its interaction with PD-L1 and PD-L2, releasing PD-1 pathway-mediated inhibition of the immune response, including the anti-tumor immune response. Tislelizumab-jsgr decreased tumor growth in xenograft models and a human PD-1 transgenic mouse model.
Approved indications
- Esophageal Cancer
- Gastric Cancer
- Esophageal Squamous Cell Carcinoma
- Gastric or gastroesophageal junction adenocarcinoma
- Unresectable or metastatic esophageal squamous cell carcinoma
- Unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma
- Unresectable or metastatic esophageal squamous cell carcinoma (ESCC)
Common side effects
- Fatigue
- Decreased Appetite
- Anemia
- Diarrhea
- Stomatitis
- Vomiting
- Dysphagia
- Rash
- Neutropenia
- Neutrophil count decreased
- Decreased sodium
- Increased glucose
Key clinical trials
- Tislelizumab in Combination With Chemotherapy as First-Line Treatment in Adults With Inoperable, Locally Advanced or Metastatic Gastric, or Gastroesophageal Junction Carcinoma (PHASE3)
- A Study of Tislelizumab (BGB-A317) in Combination With Chemotherapy as First Line Treatment in Participants With Advanced Esophageal Squamous Cell Carcinoma (PHASE3)
- A Study of Tislelizumab (BGB-A317) Versus Chemotherapy as Second Line Treatment in Participants With Advanced Esophageal Squamous Cell Carcinoma (PHASE3)
- A Study Comparing BL-B01D1 Combined With Tislelizumab Versus Platinum-containing Chemotherapy Combined With Tislelizumab as First-line Treatment in Patients With Extensive-stage Small Cell Lung Cance (PHASE3)
- A Phase IB Study to Determine the Safety and Tolerability of Canakinumab and Tislelizumab in Combination With Nab-Paclitaxel and Gemcitabine in the Neo-adjuvant Treatment of Patients With Pancreatic Cancer (PHASE1)
- Evaluation of JSKN016 Combination Therapy in Subjects With NSCLC (PHASE1)
- Efficacy and Safety Comparison Between Intensified Therapy and Conversion Therapy For Advanced HCC After Failure of First-line (PHASE2)
- A Retrospective Real-World Study Based on RATIONALE-307
Patents
| Patent | Expiry | Type |
|---|---|---|
| Biologic Exclusivity |
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
| SEC EDGAR | Revenue + earnings |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Tevimbra CI brief — competitive landscape report
- Tevimbra updates RSS · CI watch RSS
- Beigene portfolio CI