FDA Approves Tevimbra for Unresectable, Metastatic Esophageal Cancer

The Food and Drug Administration (FDA) approved Tevimbra (tislelizumab) for the treatment of adults with unresectable or metastatic esophageal squamous cell carcinoma (ESSC) that had been treated with prior systemic chemotherapy and not a PD-1 or PD-L1 inhibitor, according to a press release from BeiGene, the manufacturer of the drug.

“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,” Dr. Syma Iqbal, 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 the press release.

The approval is based on findings from the phase 3 RATIONALE 302 trial, which showed that patients lived longer when treated with Tebimbra compared to chemotherapy. Specifically, median overall survival was 8.6 months in the Tevimbra group compared to 6.3 months in the chemotherapy group.

“The RATIONALE 302 trial showed that patients with previously treated ESCC who received Tevimbra saw a clinically meaningful survival benefit, highlighting its potential as an important treatment option for these patients,” said Iqbal in the news release.

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The most common side effects, including laboratory abnormalities, that affected 20% or more of patients on 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.

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