The FDA has approved the combination of Opdivo (nivolumab) plus certain types of chemotherapy for the treatment of patients with advanced or metastatic gastric cancer, gastroesophageal junction (GEJ) cancer, and esophageal adenocarcinoma, making it the first frontline immunotherapy agent approved in this space.
The Food and Drug Administration (FDA) has approved the combination of Opdivo (nivolumab) plus certain types of chemotherapy for the treatment of patients with advanced or metastatic gastric cancer, gastroesophageal junction (GEJ) cancer, and esophageal adenocarcinoma, making it the first front-line immunotherapy agent approved in the gastric cancer space.
“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 Dr. 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, in a statement.
The approval of Opdivo, a monoclonal antibody that enhances T-cell function to fight cancer, was based on a randomized, multicenter, open-label trial that included 1,581 treatment-naïve patients with advanced or metastatic gastric cancer, GEJ cancer, and esophageal adenocarcinoma.
The 789 patients who were given Opdivo plus chemotherapy had a longer average survival rate compared to the 792 patients who were given chemotherapy alone, at 13.8 months versus 11.6 months. The most common side effects were peripheral neuropathy, nausea, fatigue, diarrhea, vomiting, decreased appetite, abdominal pain, constipation and musculoskeletal pain.
Opdivo can cause immune-related side effects, which could be serious. These include: inflammation of healthy organs such as the lungs, colon, endocrine glands and kidneys. Patients should alert their healthcare provider if they have problems with their immune system, lung or breathing problems, liver problems, have had an organ transplant, or are pregnant or plan to become pregnant.
“The FDA is committed to bringing new safe and effective treatment options like Opdivo to patients with advanced cancer,” Pazdur said.
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