Novartis Receives FDA Approval for Tevimbra in Esophageal Squamous Cell Carcinoma

Novartis today announced that the FDA has approved Tevimbra (tislelizumab-jsgr) in combination with chemotherapy for the first-line treatment of adults with unresectable locally advanced or metastatic esophageal squamous cell carcinoma (ESCC). In the Phase 3 RATIONALE-306 trial, Tevimbra plus chemotherapy demonstrated a statistically significant improvement in overall survival compared to chemotherapy alone. The median OS was 17.2 months for Tevimbra plus chemotherapy versus 10.6 months for chemotherapy alone. This approval provides patients with ESCC a new first-line treatment option combining immunotherapy with standard chemotherapy.