BeiGene Receives FDA Approval for TEVIMBRA® for the Treatment of Advanced or Metastatic Esophageal Squamous Cell Carcinoma After Prior Chemotherapy

Company Overview - BeiGene, Ltd. is a global oncology company focused on developing innovative cancer treatments, with a commitment to improving access to medicines for patients worldwide [29]. FDA Approval - The U.S. FDA has approved TEVIMBRA® (tislelizumab-jsgr) as a monotherapy for adult patients with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) after prior systemic chemotherapy that did not include a PD-(L)1 inhibitor, with availability expected in the U.S. in the second half of 2024 [1][8]. Clinical Trial Results - The approval of TEVIMBRA is based on the RATIONALE 302 trial, which demonstrated a statistically significant survival benefit, with a median overall survival of 8.6 months for TEVIMBRA compared to 6.3 months for chemotherapy (p=0.0001; HR=0.70) [2][4]. - The trial involved 512 patients across 132 research sites in 11 countries, highlighting the global reach of the study [4]. Market Potential - Esophageal cancer is projected to see nearly 957,000 new cases by 2040, indicating a 60% increase from 2020, emphasizing the need for effective treatments [5]. - TEVIMBRA has been prescribed to over 900,000 patients globally, showcasing its potential impact on cancer treatment [3]. Future Developments - The FDA is currently reviewing Biologics License Applications (BLAs) for tislelizumab as a first-line treatment for unresectable, recurrent, locally advanced, or metastatic ESCC, with target action dates set for July and December 2024 [3].