Brand Name

Tevimbra

Generic Name
Tislelizumab-jsgr
View Brand Information
FDA approval date: March 14, 2024
Classification: Programmed Death Receptor-1 Blocking Antibody
Form: Injection

What is Tevimbra (Tislelizumab-jsgr)?

Facing a cancer diagnosis can be one of life’s most difficult challenges. Advances in immunotherapy have transformed how many cancers are treated, giving patients new hope for longer, better-quality lives. Tevimbra (tislelizumab-jsgr) is one of the newest treatments in this growing field, offering a targeted, immune-based approach to fighting certain cancers. 

Tevimbra is a prescription immunotherapy medication belonging to a class of drugs called immune checkpoint inhibitors. Specifically, it is a programmed death receptor-1 (PD-1) blocking antibody. Developed by BeiGene and approved by the U.S. Food and Drug Administration (FDA) in 2024, Tevimbra is used to treat unresectable or metastatic esophageal squamous cell carcinoma (ESCC), a type of cancer that starts in the cells lining the esophagus and has spread or cannot be surgically removed. 

As a newer therapy, Tevimbra represents an important step forward for patients whose disease has progressed after other treatments, helping the immune system recognize and attack cancer cells more effectively. 

What does Tevimbra do? 

Tevimbra is used to treat adults with esophageal squamous cell carcinoma (ESCC) that has spread or cannot be removed by surgery. It is indicated for patients who have previously received chemotherapy that included platinum- and fluoropyrimidine-based drugs. 

For many people with advanced or recurrent ESCC, traditional treatments like chemotherapy may stop working or cause significant side effects. Tevimbra offers an alternative by helping the body’s immune system fight cancer. 

In clinical studies, Tevimbra was shown to extend overall survival compared to chemotherapy in previously treated patients with advanced ESCC (FDA, 2024). Some patients experienced lasting responses, with tumors shrinking or stopping growth for longer periods. While not every patient responds, those who do often report improved symptom control and quality of life. 

How does Tevimbra work? 

Our immune system is designed to detect and destroy abnormal cells, including cancer cells. However, some cancers develop ways to “hide” from immune attack by exploiting a natural checkpoint pathway in the body, specifically the PD-1 receptor found on immune cells (T cells). 

Normally, the PD-1 receptor acts as a safety mechanism to prevent overactive immune responses. When PD-1 binds to its partner proteins (PD-L1 or PD-L2) on other cells, it sends a “stop” signal to T cells, preventing them from attacking. Many cancer cells overproduce PD-L1 to deactivate T cells, allowing the cancer to grow unchecked. 

Tevimbra (tislelizumab) works by blocking the PD-1 receptor, preventing cancer cells from turning off the immune system. With PD-1 blocked, T cells can recognize and attack tumor cells again. 

This mechanism called immune checkpoint inhibition helps restore the body’s ability to mount a natural, sustained anti-tumor response. Clinically, this can lead to slower disease progression, tumor shrinkage, or even long-term remission in some cases. 

Tevimbra’s design is slightly different from earlier PD-1 inhibitors: it is engineered to minimize binding to certain immune cell receptors that could otherwise interfere with its activity. This may help maintain a stronger, more consistent immune response. 

Tevimbra side effects 

Because Tevimbra activates the immune system, it can sometimes cause the immune system to attack normal tissues, leading to immune-related side effects. These effects can range from mild to serious but are often manageable with prompt treatment. 

Common side effects may include: 

  • Fatigue 
     
  • Rash or itching 
     
  • Diarrhea 
     
  • Cough or shortness of breath 
     
  • Loss of appetite 
     
  • Nausea or mild abdominal pain 

Serious side effects (less common): 

  • Inflammation of the lungs (pneumonitis) 
     
  • Liver inflammation (hepatitis) 
     
  • Intestinal inflammation (colitis) 
     
  • Hormone gland problems (such as thyroid or adrenal dysfunction) 
     
  • Severe skin reactions 
     
  • Kidney inflammation (nephritis) 

Report new or worsening symptoms immediately (e.g., persistent cough, shortness of breath, jaundice, severe abdominal pain, extreme fatigue).  

Tevimbra is contraindicated in severe immune or certain autoimmune disorders unless a specialist advises. Use cautiously with organ transplants or active infections.  

Doctors monitor with regular blood tests and imaging to detect side effects and assess immune response. Severe reactions may lead to treatment pause/discontinuation, and corticosteroids may be prescribed for inflammation. 

Tevimbra dosage 

Tevimbra is administered intravenously by a healthcare professional every few weeks. Each infusion takes 30-60 minutes. Dosage and schedule are determined by an oncologist based on patient factors and may be used alone or with other therapies. 

Before each Tevimbra dose, doctors check liver/kidney function, hormone levels (thyroid, adrenal, pituitary), and complete blood counts. Patients should stay hydrated, attend appointments, and report side effects. Older adults tolerate Tevimbra similarly to younger patients, but careful monitoring is still crucial. 

Does Tevimbra have a generic version? 

As of 2025, Tevimbra (tislelizumab-jsgr) does not have a generic version available in the United States. It is a brand-name medication developed by BeiGene and approved by the FDA in 2024. However, international versions may exist in other markets. 

Tevimbra, a biologic therapy, will have future equivalents called biosimilars, not generics. Biosimilars are highly similar to existing biologic drugs with no clinical differences in safety or effectiveness. Currently, no biosimilar versions of tislelizumab are approved, but when available, they will undergo strict FDA review to ensure quality and efficacy match the original medication. 

Conclusion 

Tevimbra (tislelizumab-jsgr) represents a new era in cancer care, one that empowers the body’s immune system to recognize and fight cancer more effectively. For patients with advanced or metastatic esophageal squamous cell carcinoma, it provides an important treatment option when other therapies have failed. 

With careful monitoring, Tevimbra’s side effects are manageable, offering durable responses and improved survival. Open communication with your oncology team and early reporting of side effects are crucial for the best outcomes. Under expert supervision, Tevimbra provides hope and progress in advanced cancer treatment. 

References 

  1. U.S. Food and Drug Administration (FDA). (2024). FDA approves Tevimbra (tislelizumab-jsgr) for esophageal squamous cell carcinoma. Retrieved from https://www.fda.gov 
     
  1. National Cancer Institute (NCI). (2024). Immunotherapy and checkpoint inhibitors overview. Retrieved from https://www.cancer.gov 
     
  1. Mayo Clinic. (2024). Tislelizumab (intravenous route) patient information. Retrieved from https://www.mayoclinic.org 
     
  1. MedlinePlus. (2024). Cancer immunotherapy: Understanding PD-1 inhibitors. National Library of Medicine. Retrieved from https://medlineplus.gov 

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Brand Information

TEVIMBRA (tislelizumab-jsgr)
1DOSAGE FORMS AND STRENGTHS
Injection: 100 mg/10 mL (10 mg/mL) clear to slightly opalescent, colorless to slightly yellow solution in a single-dose vial.
2CONTRAINDICATIONS
None.
3ADVERSE REACTIONS
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
3.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The pooled safety population described in WARNINGS AND PRECAUTIONS reflect exposure to TEVIMBRA as a single agent in 2390 patients enrolled in three randomized open-label, active-controlled studies (BGB-A317-301, RATIONALE-302, BGB-A317-303) and six open-label, single-arm studies (BGB-A317-209, BGB-A317-208, BGB-A317-204, BGB-A317-203, BGB-A317-102, BGB-A317_Study_001), which enrolled 307 patients with esophageal squamous cell carcinoma and 2083 patients with advanced or recurrent tumors. TEVIMBRA was administered at a dose of 200 mg intravenously once every 3 weeks, except in study BGB-A317_Study_001 where patients also received other dosage regimens. Among the 2390 patients, 38% were exposed for longer than 6 months, and 23% were exposed for longer than 12 months.
3.2Postmarketing Experience
The following adverse reactions have been identified during postapproval use of TEVIMBRA. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Skin and subcutaneous tissue disorders: Stevens-Johnson syndrome, toxic epidermal necrolysis (including fatal cases).
Immune system disorders: Immune-mediated cystitis.
4DESCRIPTION
Tislelizumab-jsgr is a programmed death receptor-1 (PD-1)–blocking antibody. Tislelizumab-jsgr is an Fc-engineered humanized monoclonal IgG4 kappa antibody with an approximate molecular weight of 147 kDa. Tislelizumab-jsgr is produced in recombinant Chinese hamster ovary (CHO) cells.
TEVIMBRA (tislelizumab-jsgr) injection is a sterile, preservative-free, clear to slightly opalescent, colorless to slightly yellow solution for intravenous use, supplied in single-dose vials. Each vial contains 100 mg of tislelizumab-jsgr monoclonal antibody in 10 mL of solution, with a concentration of 10 mg/mL, and is formulated in: citric acid monohydrate (4.2 mg), histidine (17.2 mg), L-histidine hydrochloride monohydrate (8.2 mg), polysorbate 20 (2 mg), sodium citrate (59.3 mg), trehalose (650.4 mg), and Water for Injection, USP. The pH is 6.5.
5PATIENT COUNSELING INFORMATION
Advise patients to read the FDA-approved patient labeling (Medication Guide).
6PRINCIPAL DISPLAY PANEL - 10 mL Vial Carton
NDC 72579-121-01
TEVIMBRA
100 mg/10 mL
For Intravenous Infusion
Dispense with Medication Guide
One 10 mL single-dose vial
PRINCIPAL DISPLAY PANEL - 10 mL Vial Carton