The FDA approved nivolumab (OPDIVO) in combination with chemotherapy as a first-line treatment for advanced or metastatic gastric cancer, gastroesophageal junction (GEJ) cancer, and esophageal adenocarcinoma.
This approval makes nivolumab the first approved immunotherapy for first-line treatment of gastric cancer, the FDA noted. In a press release announcing the approval, 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, noted that this 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.”
Nivolumab, a programmed death receptor-1 blocking antibody, was previously approved to treat metastatic squamous non-small cell lung cancer and was granted accelerated approval to treat unresectable or metastatic melanoma. The current approval was conducted via Project Orbis, and the application was granted Priority Review and Orphan Drug designations.
“This approval was based on results from a randomized, multicenter, open-label trial of 1,581 patients with previously untreated advanced or metastatic gastric cancer, gastroesophageal junction cancer and esophageal adenocarcinoma,” the FDA explained. “The 789 patients who received [nivolumab] in combination with chemotherapy, on average, lived longer than the 792 patients who received chemotherapy alone. Median survival was 13.8 months for patients who received [nivolumab] plus chemotherapy compared to 11.6 months for patients who received chemotherapy alone.”
The most common side effects associated with nivolumab in combination with chemotherapy included peripheral neuropathy, nausea, fatigue, diarrhea, vomiting, decreased appetitie, abdominal pain, constipation, and musculoskeletal pain—and, the FDA added, the drug can also potentially cause serious conditions including pneumonitis, colitis, hepatitis, endocrinopathies, and nephtiris. “Patients should tell their healthcare 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.”
Nivolumab is manufactured by Bristol-Myers Squibb Company.
John McKenna, Associate Editor, BreakingMED™
Cat ID: 935
Topic ID: 78,935,730,188,935,192,725,925