BASEL, Switzerland & BEIJING & CAMBRIDGE, Mass. - BeiGene (NASDAQ:BGNE), Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE (LON:SSE): 688235), an oncology-focused biotechnology company, today announced the U.S. Food and Drug Administration (FDA) approval of TEVIMBRA (tislelizumab-jsgr) for adults with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) following prior systemic chemotherapy.
This marks the first U.S. indication for TEVIMBRA, which is expected to be available in the second half of 2024.
The FDA's decision is supported by the results of the RATIONALE 302 trial, a Phase 3 global study that met its primary endpoint by demonstrating a statistically significant improvement in overall survival for patients treated with TEVIMBRA compared to those receiving chemotherapy. The median overall survival was 8.6 months for the TEVIMBRA group versus 6.3 months for the chemotherapy group.
TEVIMBRA's safety profile was considered favorable, with the most common adverse reactions being metabolic and hematologic abnormalities, fatigue, musculoskeletal pain, and respiratory issues.
Dr. Mark Lanasa of BeiGene emphasized the significance of this approval for ESCC patients who have exhausted other treatment options and highlighted the ongoing review of TEVIMBRA for first-line ESCC treatment. Dr. Syma Iqbal, a specialist in gastrointestinal oncology, noted the clinical relevance of the survival benefit observed in the trial.
Esophageal cancer is among the top causes of cancer-related deaths globally, with ESCC being the most prevalent subtype. The increasing incidence of the disease underscores the urgent need for new therapies.
TEVIMBRA, a high-affinity PD-1 monoclonal antibody, is designed to enhance the body's immune response against tumors. The drug has also received approval in Europe for advanced or metastatic ESCC after prior chemotherapy and is under review for additional indications.
BeiGene is conducting multiple clinical trials to potentially enable further registrations of TEVIMBRA across various tumor types and treatment settings. The company has highlighted the drug's potential to improve survival and quality of life for cancer patients worldwide.
This news article is based on a press release statement and does not include any independent verification of the data.
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