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The EC’s approval was based on positive results from a Phase III clinical trial that demonstrated a statistically significant and clinically meaningful improvement in patients compared to chemotherapy.
Bristol Myers Squibb announced on Nov. 24, 2020 that the European Commission (EC) approved Opdivo (nivolumab), a programmed death-1 immune checkpoint inhibitor, for the second-line treatment of unresectable advanced, recurrent, or metastatic esophageal squamous cell carcinoma (ESCC) in adults who have had prior fluoropyrimidine- and platinum-based combination chemotherapy.
The EC’s decision is based on results from a Phase III study (sponsored by Ono Pharmaceutical, Japan) that demonstrated a statistically significant and clinically meaningful improvement in overall survival in patients who received Opdivo versus chemotherapy. The safety profile for Opdivo was favorable compared with chemotherapy and consistent with previously reported studies of Opdivo in other solid tumors, Bristol Myers Squibb reported in a company press release.
“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,” said Ian M. Waxman, MD, development lead, gastrointestinal cancers, Bristol Myers Squibb, in the press release. “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.”
In addition to this approval in the European Union, Opdivo has been approved in five countries, including the United States and Japan, for the second-line treatment of patients with unresectable advanced, recurrent or metastatic ESCC.
Source: Bristol Myers Squibb