Opdivo OK’d for Gastric Cancer

FDA has approved Bristol-Myers Squibb’s Opdivo (nivolumab) for combination use with chemotherapy for the initial treatment of patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer and esophageal adenocarcinoma. An agency release says this is the first FDA-approved immunotherapy for the first-line treatment of gastric cancer.

The monoclonal antibody inhibits tumor growth by enhancing T-cell function, FDA says. Its efficacy was evaluated in a randomized trial involving 1,581 patients with previously untreated advanced or metastatic gastric cancer, gastroesophageal junction cancer and esophageal adenocarcinoma. “The 789 patients who received Opdivo in combination with chemotherapy, on average, lived longer than the 792 patients who received chemotherapy alone,” it says. “Median survival was 13.8 months for patients who received Opdivo plus chemotherapy compared to 11.6 months for patients who received chemotherapy alone.”