BeiGene, soon to be renamed as BeOne Medicines, has received European Commission approval for its drug TEVIMBRA (tislelizumab) combined with chemotherapy as a first-line treatment for esophageal squamous cell carcinoma (ESCC) and gastric or gastroesophageal junction (G/GEJ) adenocarcinoma. This approval is based on compelling data from the RATIONALE-305 and 306 trials, highlighting TEVIMBRA's unique clinical profile and its potential to significantly improve outcomes for patients with advanced cancers. TEVIMBRA has been shown to increase median overall survival and reduce the risk of death in patients with unresectable, locally advanced, or metastatic ESCC and G/GEJ cancers, expressing PD-L1 with a TAP score of ≥ 5%.
TEVIMBRA, an anti-PD-1 monoclonal antibody, is a central component of BeiGene's solid tumor portfolio and is approved in 42 countries, with over 1.3 million patients treated globally. The drug has shown effectiveness across multiple tumor types and disease settings, with a global clinical development program involving nearly 14,000 patients. BeiGene's commitment to innovative cancer treatments is underscored by this latest approval, which adds to the company's six indications approved in the European Union within just over a year. TEVIMBRA's approval is expected to offer new hope to patients with advanced esophageal and gastric cancers, underscoring the urgent need for more effective treatment options in these rapidly fatal diseases.
