What is it prescribed for?
TEVIMBRA is 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. Tevimbra was approved on March 13, 2024.
What is the name of the drug and what does it do?
Tevimbra (pronounced teh-VIM-brah), (generic name: tislelizumab), is a medication indicated for the treatment of adult patients with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) after prior systemic chemotherapy that did not include a PD-(L)1 inhibitor.
How does it work?
Tevimbra is a programmed death receptor-1 (PD-1) blocking antibody. PD-1 is a checkpoint protein on T-cells, which, when engaged, can inhibit the immune response. By blocking PD-1, Tevimbra allows T-cells to remain active and attack cancer cells. This helps the immune system to better recognize and fight the cancer cells in ESCC.
What did the research discover?
Clinical trials demonstrated that Tevimbra is effective in treating ESCC. In the RATIONALE-302 study, patients treated with Tevimbra had a statistically significant improvement in overall survival compared to those who received investigator’s choice chemotherapy. The median overall survival was 8.6 months for Tevimbra compared to 6.3 months for chemotherapy. Additionally, the objective response rate (ORR) was higher in the Tevimbra group (15.2%) compared to the chemotherapy group (6.6%), indicating a better response to the treatment.
What are some of the side effects?
- Increased glucose
- Decreased hemoglobin
- Decreased lymphocytes
- Decreased sodium
- Decreased albumin
- Increased alkaline phosphatase
- Anemia
- Fatigue
- Increased AST (aspartate aminotransferase)
- Musculoskeletal pain
- Decreased weight
- Increased ALT (alanine aminotransferase)
- Cough
What are the dosage recommendations and how is it prescribed?
The recommended dose of Tevimbra is 200 mg administered as an intravenous infusion once every 3 weeks. The first infusion should be administered over 60 minutes, and if tolerated, subsequent infusions may be administered over 30 minutes. The treatment continues until disease progression or unacceptable toxicity occurs.
Source:
BeiGene USA, Inc. Tevimbra (tislelizumab) for injection, for intravenous use. Prescribing Information. 2024. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761232Orig1s000lbl.pdf
