BeiGene, Ltd., a global, science-driven biotechnology company focused on developing innovative and affordable medicines to improve treatment outcomes and access for patients worldwide, announced that marketing authorization applications (MAA) for tislelizumab, submitted by Novartis, the license holder in Europe, have been validated for regulatory review by the European Medicines Agency (EMA) for patients with advanced or metastatic esophageal squamous cell carcinoma (ESCC) after prior systemic chemotherapy and for patients with non-small cell lung cancers (NSCLC).
The MAA for tislelizumab in NSCLC is supported by clinical results from three BeiGene-sponsored trials of 1,499 patients, including the global randomized, open-label, Phase 3 RATIONALE 303 trial comparing tislelizumab to docetaxel in the second- or third-line setting in patients with locally advanced or metastatic NSCLC who have progressed on prior platinum-based chemotherapy. In this trial, 805 patients in 10 countries across the Americas, Europe, Asia, and Oceania were enrolled in the trial, randomized 2:1 to either the tislelizumab arm or the docetaxel arm. Read more here.