The agency approved nivolumab 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, making it the first approved first-line immunotherapy for this patient population.
The FDA approved nivolumab (Opdivo) in combination with certain types of chemotherapy for the frontline treatment of patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer and esophageal adenocarcinoma, making it the first approved immunotherapy for this patient population.1
“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, said in a press release from the agency. “The FDA is committed to bringing new safe and effective treatment options like Opdivo to patients with advanced cancer.”
The agency based the approval on data from the randomized, multicenter, open-label phase 3 CheckMate-649 trial, designed to evaluate nivolumab – a monoclonal antibody that inhibits tumor growth by enhancing T-cell function – plus chemotherapy in 1,581 patients with previously untreated advanced or metastatic gastric cancer, gastroesophageal junction cancer and esophageal adenocarcinoma.
Of the 789 patients treated in the nivolumab arm, median overall survival was 13.8 months, compared with 11.6 months for patients who received chemotherapy alone.
The most common adverse events in the combination arm included peripheral neuropathy, nausea, fatigue, diarrhea, vomiting, decreased appetite, abdominal pain, constipation, and musculoskeletal pain.
“Opdivo can cause serious conditions known as immune-mediated side effects, including inflammation of healthy organs such as the lungs (pneumonitis), colon (colitis), liver (hepatitis), endocrine glands (endocrinopathies) and kidneys (nephritis),” according to the release. “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 granted the approval under Project Orbis, an initiative of the FDA Oncology Center of Excellence that provides a framework for concurrent submission and review of oncology drugs among international partners.
FDA News Release. FDA Approves First Immunotherapy for Initial Treatment of Gastric Cancer. Published April 16, 2021. https://www.fda.gov/news-events/press-announcements/fda-approves-first-immunotherapy-initial-treatment-gastric-cancer. Accessed April 16, 2021.