Tevimbra FDA Approval History
Last updated by Judith Stewart, BPharm on March 25, 2024.
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
Tevimbra (tislelizumab-jsgr) is a humanized immunoglobulin G4 (IgG4) anti-programmed cell death protein 1 (PD-1) monoclonal antibody indicated for the treatment of adult patients with unresectable or metastatic esophageal squamous cell carcinoma after prior systemic chemotherapy that did not include a PD-(L)1 inhibitor .
- Esophageal squamous cell carcinoma (ESCC) is a cancer that arises in the epithelial cells that line the upper part of the esophagus. It is the most common type of esophageal cancer.
- 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 include anemia, fatigue, musculoskeletal pain, decreased weight, and cough. Common laboratory abnormalities include increased glucose, decreased hemoglobin, decreased lymphocytes, decreased sodium, decreased albumin, increased alkaline phosphatase, and increased AST.
Development timeline for Tevimbra
Further information
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