FDA Approves First Immunotherapy for Initial Treatment of Ga
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The U.S. Food and Drug Administration approved 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. This is the first FDA-approved immunotherapy for the first-line treatment of gastric cancer.

Opdivo is a monoclonal antibody that inhibits tumor growth by enhancing T-cell function. Median survival was 13.8 months for patients who received Opdivo plus chemotherapy compared to 11.6 months for those who received chemotherapy alone. The study evaluated 1,581 patients with previously untreated advanced or metastatic gastric cancer.

The most common side effects of Opdivo in combination with chemotherapy include peripheral neuropathy, nausea, fatigue, diarrhea, vomiting and abdominal pain. Patients should tell their healthcare 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.

Opdivo received Priority Review and Orphan Drug designations for this indication. Breakthrough Therapy designation is designed to expedite the development and review of drugs that are intended to treat a serious condition. Preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint.

The FDA granted approval to Bristol-Myers Squibb Company. This review was conducted under Project Orbis, an initiative of the FDA Oncology Center of Excellence. Project Orbis provides a framework for concurrent submission and review of oncology drugs among international partners. For this review, the FDA collaborated with the Australian Therapeutic Goods Administration, the Brazilian Health Regulatory Agency, Health Canada and Switzerland’s Swissmedic.

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