The US FDA (Food and Drug Administration) has accepted for review BeiGene’s Biologics License Application (BLA) for its anti-PD-1 antibody tislelizumab to treat patients with reoccurring locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) following prior therapy. Based on RATIONALE 302 results, a randomized, open-label, multicenter global Phase 3 trial (NCT03430843), the trial aims to study tislelizumab’s efficacy and safety in comparison with an investigator’s choice chemotherapy as a second-line treatment for ESCC patients. Tislelizumab is currently under review from regulatory bodies in both US and China.
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