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Opdivo is the first FDA-approved immunotherapy for the first-line treatment of gastric cancer.
FDA approved Bristol-Myers Squibb’s Opdivo (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.
Opdivo is the first FDA-approved immunotherapy for the first-line treatment of gastric cancer. There are 21 indications for the drug across 12 types of cancer.
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“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 press release.
There are approximately 28,000 new diagnoses of gastric cancer each year in the U.S. and with currently available therapy, overall survival is generally poor, FDA said. The survival rate for all stages is 32%, and the 5-year survival rate for advanced or metastatic gastric cancer is only 5%.
FDA’s approval was based on 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 median survival was 13.8 months for patients who received Opdivo plus chemotherapy compared to 11.6 months for patients who received chemotherapy alone.
In an exploratory analysis of all patients, 55% of patients on Opdivo in combination with chemotherapy were alive at one year versus 48% of patients on chemotherapy alone, BMS said in a press release.
The most common side effects of Opdivo in combination with chemotherapy include peripheral neuropathy (damage to the nerves outside of the brain and spinal cord), nausea, fatigue, diarrhea, vomiting, decreased appetite, abdominal pain, constipation and musculoskeletal pain.
Opdivo can cause immune-mediated side effects, including inflammation of healthy organs such as the lungs, colon, liver, endocrine glands, and kidneys.