Posted by Michael Wonder on 11 Jun 2020
U.S. Food and Drug Administration approves Opdivo (nivolumab) for the treatment of patients with advanced oesophageal squamous cell carcinoma after prior fluoropyrimidine- and platinum-based chemotherapy
10 June 2020 - Opdivo demonstrated superior overall survival benefit compared to docetaxel or paclitaxel.
Bristol Myers Squibb today announced that Opdivo (nivolumab) was approved by the U.S. FDA for the treatment of patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma 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 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).
