Opdivo EC approval : Bristol Myers Squibb (BMS) has secured approval from the European Commission (EC) for its immunotherapy Opdivo (nivolumab) as a second-line treatment for unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) in adults.
The approval of the programmed death-1 (PD-1) immune checkpoint inhibitor is for patients who were previously subjected to fluoropyrimidine- and platinum-based combination chemotherapy.
It was granted based on the findings of the phase 3 ATTRACTION-3 trial, a study sponsored by Japan-based Ono Pharmaceutical, which showed a statistically significant and clinically meaningful improvement in overall survival (OS) in patients treated with Opdivo versus chemotherapy.
Ian M. Waxman – Bristol Myers Squibb gastrointestinal cancers development lead, commenting on Opdivo EC approval, said: “Today’s approval marks a critically important milestone for those living with esophageal squamous cell carcinoma, as this is the first time an immunotherapy treatment option has been approved in the European Union for this patient population.
“We are proud of our work in advancing treatment options for people living with upper gastrointestinal cancers, and we look forward to working with European stakeholders to bring Opdivo to more eligible patients who may benefit.”
Apart from the EU, Opdivo has approval across five countries, including the US and Japan, for the same indication.