FDA Approves Frontline Nivolumab for Gastric Cancers

The FDA approved nivolumab (Opdivo) plus certain types of chemotherapy for the treatment of patients with advanced or metastatic gastric cancer, gastroesophageal junction (GEJ) cancer, and esophageal adenocarcinoma. This is the first frontline immunotherapy regimen approved for gastric cancer.

“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 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, in a statement.

The approval 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 – 789 of whom received nivolumab plus chemotherapy.

Those in the nivolumab/chemotherapy arm had longer average survival than those who were given chemotherapy alone, 13.8 months and 11.6 months, respectively.

Most common adverse events from nivolumab – a monoclonal antibody that enhances T-cell function to fight cancer – were peripheral neuropathy, nausea, fatigue, diarrhea, vomiting, decreased appetite, abdominal pain, constipation and musculoskeletal pain.

Nurses should also look out for immune-related adverse events, which could be serious. They include: pneumonitis, colitis, hepatitis, endocrinopathies, and nephritis. Patients and providers must communicate if the patient has any issues with their immune system, lung or breathing problems, liver problems, have had an organ transplant, or are pregnant/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.