Tislelizumab

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 of unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma whose tumors express PD-L1 (≥1).

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.

Recommended Dosage: Esophageal Cancer 150 mg every 2 weeks or 200 mg every 3 weeks or 300 mg every 4 weeks or 400 mg every 6 weeks in combination with platinum-containing chemotherapy for first-line treatment of unresectable or metastatic ESCC. 150 mg every 2 weeks or 200 mg every 3 weeks or 300 mg every 4 weeks or 400 mg every 6 weeks as a single agent for treatment of unresectable or metastatic ESCC. Gastric Cancer 150 mg every 2 weeks or 200 mg every 3 weeks or 300 mg every 4 weeks or 400 mg every 6 weeks in combination with platinum and fluoropyrimidine-based chemotherapy. Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma 150 mg every 2 weeks or 200 mg every 3 weeks or 300 mg every 4 weeks or 400 mg every 6 weeks in combination with zanidatamab-hrii and fluoropyrimidine- and platinum- containing chemotherapy.

None. None.

Immune-Mediated Adverse Reactions: Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue, including the following: immune-mediated pneumonitis, immune-mediated colitis, immune-mediated hepatitis, immune-mediated endocrinopathies, immune-mediated nephritis with renal dysfunction, immune-mediated dermatologic adverse reactions, and solid organ transplant rejection. Monitor for early identification and management. Evaluate liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment. Withhold or permanently discontinue TEVIMBRA based on the severity of reaction. Infusion-Related Reactions: Slow the rate of infusion, interrupt, or permanently discontinue based on severity of infusion reaction.

The following clinically significant adverse reactions are discussed in more detail in other sections of the label: Severe and fatal immune-mediated adverse reactions Infusion-related reactions Most common adverse reactions (≥20%), including laboratory abnormalities, were: TEVIMBRA in combination with platinum-containing chemotherapy: decreased neutrophil count, decreased sodium, increased glucose, anemia, fatigue, decreased appetite, increased aspartate aminotransferase (AST), decreased potassium, increased serum creatinine, decreased calcium, increased alanine aminotransferase (ALT), diarrhea, stomatitis, and vomiting. TEVIMBRA 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.

Store in a refrigerator at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. Do not freeze. Do not shake.