First Immunotherapy for Initial Gastric Cancer Treatment Approved by FDA

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The US FDA has 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.

"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. "The FDA is committed to bringing new safe and effective treatment options like Opdivo to patients with advanced cancer."

Approximately 28,000 new diagnoses of gastric cancer are made each year in the US, however, overall survival is generally poor. The rate of cure with resection is very low and the survival rate for all stages is 32%. The 5-year survival rate for advanced or metastatic gastric cancer is 5%.

Opdivo from Bristol-Meyers Squibb Company, 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. The 789 patients who received Opdivo in combination with chemotherapy, on average, lived longer than the 792 patients 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 (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 serious conditions known as immune-mediated side effects, including inflammation of healthy organs such as the lungs (pneumonitis), colon (colitis), liver (hepatitis), endocrine glands (endocrinopathies) and kidneys (nephritis). 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. This review was conducted under Project Orbis, an initiative of the FDA Oncology Center of Excellence.

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First Immunotherapy for Initial Gastric Cancer Treatment Approved by FDA.  Appl Rad Oncol. 

By News Release| April 20, 2021

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