email article
The FDA approved nivolumab (Opdivo) plus chemotherapy as the first immunotherapy-containing regimen for previously untreated advanced/metastatic gastric or esophageal cancer.
The approval encompasses gastric, gastroesophageal junction (GEJ), and esophageal adenocarcinoma and follows FDA priority review designation for the nivolumab-chemotherapy combination earlier this year.
"Today's approval is the first treatment in more than a decade to show a survival benefit for patients with advanced or metastatic cancer who are being treated for the first time," said Richard Pazdur, MD, of the FDA Center for Drug Evaluation and Research, in a statement. "The FDA is committed to bringing new safe and effective treatment options like Opdivo to patients with advanced cancer."