FDA nod for Opdivo in esophageal squamous cell carcinoma

On June 10, 2020, the US Food and Drug Administration approved Opdivo (nivolumab), from Bristol-Myers Squibb (NYSE: BMY), for 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 III ATTRACTION-3 trial in which Opdivo (n=210) demonstrated superior overall survival (OS) versus taxane chemotherapy (n=209) (investigator’s choice of docetaxel or paclitaxel) (hazard ratio [HR] 0.77; 95% confidence interval [CI]: 0.62 to 0.96; p=0.0189). The median OS was 10.9 months (95% CI: 9.2 to 13.3) for Opdivo compared to 8.4 months (95% CI: 7.2 to 9.9) for docetaxel or paclitaxel.

Opdivo, a blockbuster PD-1 inhibitor, is the first approved immunotherapy in this setting regardless of tumor PD-L1 expression level, said B-MS, whose shares were down 1.9% at $59.02 pre-market despite the positive news.