FDA clears Opdivo as first-line gastric cancer treatment

The Food and Drug Administration has given its stamp of approval to Bristol-Myers Squibb for a new indication of Opdivo (nivolumab). The drug now is approved, in combination with certain types of chemotherapy, for the initial treatment of patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer and esophageal adenocarcinoma. This is the first FDA-approved immunotherapy for the first-line treatment of gastric cancer.

"Today's approval is the first treatment in more than a decade to show a survival benefit for patients with advanced or metastatic gastric cancer who are being treated for the first time," said Richard Pazdur, director of the FDA's Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA's Center for Drug Evaluation and Research. "The FDA is committed to bringing new safe and effective treatment options like Opdivo to patients with advanced cancer."

Opdivo is a monoclonal antibody that inhibits tumor growth by enhancing T-cell function.