Opdivo (nivolumab) has become the first immunotherapy to be approved for a gastroesophageal cancer in the European Union.
The Bristol Myers Squibb (NYSE: BMY) drug has been approved for the treatment of adults with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after prior fluoropyrimidine- and platinum-based combination chemotherapy.
The European Commission’s decision is based on results from the Phase III ATTRACTION-3 trial, a study sponsored by BMS’ partner Ono Pharmaceutical (TYO: 4528), which demonstrated a statistically-significant and clinically-meaningful improvement in overall survival (OS) in patients who received Opdivo versus chemotherapy.
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