BeiGene, Ltd. announced that the European Commission has approved TEVIMBRA® (tislelizumab) in combination with chemotherapy for the first-line treatment of esophageal squamous cell carcinoma (ESCC) and gastric or gastroesophageal junction (G/GEJ) adenocarcinoma.
“Patients diagnosed with advanced gastric and esophageal cancers confront median survival times measured in months, not years—highlighting the urgent need for more effective treatment options,” said Prof. Florian Lordick, Director and Professor of Oncology of the University Cancer Center Leipzig, Germany. “The compelling data from the RATIONALE-305 and 306 trials underscore the unique clinical profile of tislelizumab and its potential to deliver meaningful improvements in outcomes for eligible patients, offering new hope where it’s needed most.”
In ESCC, the expanded indication is for TEVIMBRA in combination with platinum-based chemotherapy for the first-line treatment of adult patients with unresectable, locally advanced or metastatic cancer whose tumors express PD-L1 with a tumor area positivity (TAP) score ≥ 5%. In G/GEJ adenocarcinoma, the expanded indication is for TEVIMBRA in combination with platinum- and fluoropyrimidine-based chemotherapy for the first-line treatment of adult patients with HER2-negative locally advanced unresectable or metastatic cancer whose tumors express PD-L1 with a TAP score ≥ 5%.
“As the cornerstone of our solid tumor portfolio, TEVIMBRA is central to BeiGene’s commitment to delivering innovative treatments to as many people living with cancer as possible, with more than 1.3 million patients already treated with the medicine worldwide," said Mark Lanasa, M.D., Ph.D., Chief Medical Officer, Solid Tumors at BeiGene. "In just over a year, we have achieved approvals in the European Union across six indications, and we look forward to working to ensure that patients across Europe have rapid and broad access to TEVIMBRA.”
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