On Jun. 11, 2020, Bristol-Myers Squibb announced that Opdivo (nivolumab) was approved by the FDA for the treatment of patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after prior fluoropyrimidine- and platinum-based chemotherapy.

This application was granted Priority Review Designation by the FDA, and the approval is based on the Phase 3 ATTRACTION-3 trial in which Opdivo (n=210) demonstrated superior overall survival (OS) versus taxane chemotherapyl. Opdivo was the first approved immunotherapy in this setting regardless of tumor PD-L1 expression level.