FDA Approval Alert: The Need-to-Know | Tislelizumab/Chemotherapy in Unresectable or Metastatic PD-L1+ ESCC
In March 2025, the FDA approved tislelizumab-jsgr plus platinum-based chemotherapy as a frontline therapy for adult patients with unresectable or metastatic PD-L1–positive esophageal squamous cell carcinoma.
Data from the RATIONALE-306 trial support the approval of tislelizumab plus chemotherapy in unresectable or metastatic esophageal squamous cell carcinoma.