Tevimbra FDA Approval History
Last updated by Judith Stewart, BPharm on March 5, 2025.
FDA Approved: Yes (First approved March 13, 2024)
Brand name: Tevimbra
Generic name: tislelizumab-jsgr
Dosage form: Injection
Company: BeiGene, Ltd.
Treatment for: Esophageal Carcinoma, Gastric Cancer
Tevimbra (tislelizumab-jsgr) is a humanized immunoglobulin G4 (IgG4) anti-programmed cell death protein 1 (PD-1) monoclonal antibody for use in the treatment of esophageal cancer and gastric cancer.
- Tevimbra is 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 of unresectable or metastatic HER2- negative gastric or gastroesophageal junction adenocarcinoma whose tumors express PD-L1 (≥1). - Esophageal squamous cell carcinoma (ESCC) is a cancer that arises in the epithelial cells that line the upper part of the esophagus. Gastric cancer is cancer of the stomach and gastroesophageal junction cancer occurs at the gastroesophageal junction where the esophagus joins the stomach.
- Tevimbra is a PD-1 antibody that has high affinity and binding specificity against PD-1, a protein found on immune T cells. When proteins on cancer cells bind to the PD-1 receptor on the T cells, the T cells are inactivated, which stops them from killing the cancer cells. Tevimbra works by blocking PD-1, so the T cells remains active and increase the ability of the T cells to kill the cancer cells. Tevimbra also minimizes binding to Fc-gamma (Fcγ) receptors, which is a potential mechanism of anti–PD-1 resistance.
- Tevimbra is administered by intravenous infusion once every 3 weeks. The first infusion is administered over 60 minutes, but subsequent infusions may be administered over 30 minutes if tolerated.
- Warnings and precautions associated with Tevimbra include immune-mediated adverse reactions, infusion-related reactions, complications of allogeneic hematopoietic stem cell transplantation (HSCT), and embryo-fetal toxicity.
- Common adverse reactions:
- when used in combination with platinum-containing chemotherapy: decreased neutrophil count, decreased sodium, increased glucose, anemia, fatigue, decreased appetite, increased AST, decreased potassium, increased serum creatinine, decreased calcium, increased ALT, diarrhea, stomatitis, and vomiting.
- when used as a single agent: increased glucose, decreased hemoglobin, decreased lymphocytes, decreased sodium, decreased albumin, increased alkaline phosphatase, anemia, fatigue, increased AST, musculoskeletal pain, decreased weight, increased ALT, and cough.
- when used in combination with platinum and fluoropyrimidine-based chemotherapy: nausea, fatigue, decreased appetite, anemia, peripheral sensory neuropathy, vomiting, decreased platelet count, decreased neutrophil count, increased aspartate aminotransferase, diarrhea, abdominal pain, increased alanine aminotransferase, decreased white blood cell count, decreased weight, and pyrexia.
Development timeline for Tevimbra
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.