BeOne Medicines' Tevimbra (Tislelizumab-jsgr) Monograph for Esophageal/Gastric Cancer

Published: June 06, 2025

Tevimbra (tislelizumab-jsgr) is an FDA-approved cancer treatment option for people with esophageal cancer and gastric cancer. The treatment can be used in varying doses in two-, three-, or four-week intervals for adults as a first-line or single-agent treatment of unresectable or metastatic esophageal squamous cell carcinoma and in combination with platinum and fluoropyrimidine-based chemotherapy for gastric cancer.

Medication Overview

Brand Name: Tevimbra
Generic Name: tislelizumab-jsgr
Treatment For: Esophageal cancer, gastric cancer
Manufacturer: BeOne Medicines
FDA Approval: March 2024

Indicated Condition	Indication	Age Group	Date Approved
Esophageal Cancer	First-line treatment of esophageal squamous cell carcinoma: in combination with platinum-containing chemotherapy, is indicated for the first-line treatment of adults with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) whose tumors express PD-L1 (≥1). Previously treated esophageal squamous cell carcinoma: as a single agent, is indicated for the treatment of adults with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) after prior systemic chemotherapy that did not include a PD-(L)1 inhibitor.	Adults	March 2024
Gastric Cancer	in combination with platinum and fluoropyrimidine-based chemotherapy, is indicated for the first-line treatment of adults with unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma (G/GEJ) whose tumors express PD-L1 (≥1).	Adults	March 2024

Warnings and Precautions

See full prescribing information for complete boxed warning.

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.
Complications of Allogeneic Hematopoietic Stem Cell Transplantation (HSCT): Fatal and other serious complications can occur in patients who receive allogeneic HSCT before or after being treated with a PD-1/PD-L1 blocking antibody.
Embryo-Fetal Toxicity: Can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception.

Dosage and Administration

Esophageal Cancer:

150 mg every 2 weeks or 200 mg every 3 weeks or 300 mg every 4 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 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 in combination with platinum and fluoropyrimidine-based chemotherapy.

Contraindications

None listed.

Common Adverse Reactions

Tevimbra 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.
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.
Tevimbra 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.

Example of Tislelizumab in Guidelines:

Recurrent and Metastatic Head and Neck Cancers

American Society of Clinical Oncology
Published: December 15, 2022
Recommendation 4.1: Toripalimab, camrelizumab, or tislelizumab, with gemcitabine and cisplatin, should be offered as first-line treatment for patients with recurrent or metastatic nasopharyngeal cancer (Type: Evidence based, benefits outweigh harms; Evidence quality: High; Strength of recommendation: Strong).

Please note: This article is current as of May 29, 2025. Consult our clinical guidelines library or drug information tool to ensure you always have the most up-to-date information.