FDA Approves Bristol Myers Squibb’s Opdivo for Advanced Esophageal Squamous Cell Carcinoma

The FDA has approved Bristol Myers Squibb’s immunotherapy Opdivo (nivolumab) for treatment of patients with advanced esophageal squamous cell carcinoma who were previously treated with fluoropyrimidine- and platinum-based chemotherapy.

The approval was based on positive results from a phase 3 study in which patients treated with Opdivo demonstrated superior overall survival compared to those given chemotherapy.

Opdivo is the first approved immunotherapy for this patient population.