This is the first immunotherapy approved for the frontline treatment of gastric cancers, the agency says in a press release.
The approval comes after nivolumab received Priority Review and Orphan Drug designations for this indication. There are approximately 28,000 new diagnoses of gastric cancer annually in the United States, and overall survival is generally poor with currently available therapy, points out the FDA.
“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,” Richard Pazdur, MD, 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, states in an FDA press release.
Efficacy in the gastric cancer setting was demonstrated in the randomized, phase 3, open-label CheckMate 649 study of 1,518 untreated patients. Median survival was 13.8 months among those treated with nivolumab, compared with 11.6 months with chemotherapy alone (hazard ratio, 0.80; P = .0002).
Common side effects experienced by patients in the nivolumab group included peripheral neuropathy, nausea, fatigue, diarrhea, vomiting, decreased appetite, abdominal pain, constipation, and musculoskeletal pain.
Nivolumab is also approved for numerous other cancers. Other known adverse effects include immune-mediated inflammation of the lungs, colon, liver, endocrine glands, and kidneys.
“Patients should tell their health care providers if they have immune system problems, lung or breathing problems, liver problems, have had an organ transplant, or are pregnant or plan to become pregnant before starting treatment,” the FDA states.
A version of this article first appeared on.