The U.S. Food and Drug Administration has approved Bristol-Myers Squibb Co.’s Opdivo (nivolumab), in combination with certain types of chemotherapy, to become the first immunotherapy for the initial treatment of gastric cancer.
In a statement, the regulator said the approval is for the first-line treatment of patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer and esophageal adenocarcinoma.
Opdivo received Priority Review and Orphan Drug designations for this indication.
Among the around 28,000 new diagnoses of gastric cancer each year in the U.S, the rate of cure with resection is very low and the survival rate for all stages is 32% with currently available therapy, the FDA said. The 5-year survival rate for advanced or metastatic gastric cancer is 5%.
Opdivo is a monoclonal antibody that inhibits tumor growth by enhancing T-cell function. Its efficacy was evaluated in a randomized, multicenter, open-label trial of 1,581 patients with previously untreated advanced or metastatic gastric cancer, gastroesophageal junction cancer and esophageal adenocarcinoma.
In the trial, it was found that the patients who received Opdivo in combination with chemotherapy, on average, lived longer than those who received chemotherapy alone. Median survival was 13.8 months for patients who received Opdivo plus chemotherapy compared to 11.6 months for patients who received chemotherapy alone.
The most common side effects of Opdivo in combination with chemotherapy include peripheral neuropathy, nausea, fatigue, diarrhea, vomiting, decreased appetite, abdominal pain, constipation and musculoskeletal pain.
The review was conducted under Project Orbis, an initiative of the FDA Oncology Center of Excellence.
Richard Pazdur, director of the FDA’s Oncology Center of Excellence, said, “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.”
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