Approved: New Gastric Cancer Rx

The US Food and Drug Administration (FDA) has approved a new first-line treatment for gastric cancer.

The FDA approved Opdivo (nivolumab) to treat advanced gastric cancer, esophageal adenocarcinoma and gastroesophageal junction cancer.

This drug is the first FDA-approved first-line treatment 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 Dr. Richard Pazdur, director of the FDA’s Oncology Center of Excellence and acting director of the FDA's Office of Oncologic Diseases, in a press release.

The FDA noted that overall survival for gastric cancer is low. And survival for advanced gastric cancer is even lower.

But newly approved Opdivo may help with that. The FDA approved this new gastric cancer immunotherapy drug based on the results of a trial of nearly 1,600 patients with untreated advanced gastric cancer, esophageal adenocarcinoma or gastroesophageal junction cancer.

Half of the study participants received Opdivo and chemotherapy. The other half received only chemotherapy.

Those who received Opdivo lived longer on average than those who only received chemotherapy. For the patients who received Opdivo, median survival time was 13.8 months. For the patients who received only chemo, median survival was 11.6 months.

Common side effects of Opdivo included stomach pain, constipation, muscle pain, nausea, vomiting, tiredness, diarrhea, reduced appetite and peripheral neuropathy (damage to nerves near the spinal cord and brain).

This medication may also cause serious conditions called immune-mediated side effects. These can include inflammation of healthy organs like the liver, colon, lungs, kidneys and endocrine glands. If you have immune system problems, trouble breathing, liver issues, a recent organ transplant, or a current or planned pregnancy, tell your doctor before taking this drug.

The FDA approved Opdivo for this use for Bristol-Myers Squibb Company.