FDA Approves Tevimbra for Esophageal Cancer


Tevimbra will be available in the second half of this year and is indicated as a second-line treatment of patients with esophageal squamous cell carcinoma, which is an aggressive cancer.

The FDA has approved Tevimbra (tislelizumab-jsgr) as monotherapy to treat adult patients with unresectable or metastatic esophageal squamous cell carcinoma (ESCC). It is indicated to be used after prior systemic chemotherapy that did not include a PD-(L)1 inhibitor.

The American Cancer Society estimates that in 2024, there will be about 22,370 new esophageal cancer cases diagnosed and about new 16,130 deaths. Esophageal squamous cell carcinoma is the most common subtype, where cancer forms in the flat, thin lining of the esophagus. It has an expected five-year survival rate of less than 6% for those with metastases.

Syma Iqbal, M.D.

Syma Iqbal, M.D.

“Patients diagnosed with advanced or metastasized ESCC, the most common histologic subtype of esophageal cancer, often progress following initial therapy and are in need of new options,” Syma Iqbal, M.D., associate professor of Clinical Medicine, section chief Gastrointestinal Oncology, division of Medical Oncology and Cancer Physician in Chief, Norris Comprehensive Cancer Center, Keck School of Medicine, University of Southern California, said in a press release.

Developed by BeiGene, Tevimbra is humanized IgG4 anti-PD-1 monoclonal antibody designed to aid the body’s immune cells to detect and fight tumors. It will be available in the United States in the second half of 2024. A company spokesperson said pricing will be available closer to launch. BeiGene is currently in discussions with payers regarding coverage.

The approval is based on the RATIONALE 302 trial, which met its primary end point in the intention-to-treat (ITT) population. In the ITT population, the median overall survival (OS) in the Tevimbra arm was 8.6 months compared with 6.3 months in the chemotherapy arm. The most common adverse reactions for Tevimbra were 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.

Related: FDA Sets Review Date for Tislelizumab in Stomach Cancer

The FDA is also reviewing biologics license applications (BLAs) for Tevimbra as a first-line treatment for patients with locally advanced, or metastatic esophageal squamous cell carcinoma with a target action data in July 2024 and for patients with locally advanced unresectable or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma with a target action date of December 2024.

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