The FDA approved tislelizumab-jsgr (Tevimbra, BeiGene) as monotherapy for adult patients with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) after prior systemic chemotherapy that did not include a PD-L1 inhibitor.
The approval is based on the RATIONALE-302 trial, a global, phase 3, randomized, open-label study designed to investigate the efficacy and safety of tislelizumab-jsgr when compared with investigator’s choice of chemotherapy as a second-line treatment
MARCH 19, 2024