Immuno-Oncology Resource Center

Immuno-Oncology Resource Center

April 16, 2021
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FDA approves Opdivo for initial treatment of advanced gastrointestinal cancers

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The FDA approved nivolumab as part of combination therapy for certain patients with gastrointestinal malignancies.

The approval applies to use of the agent with certain types of chemotherapy as initial treatment for advanced or metastatic gastric cancer, gastroesophageal junction cancer or esophageal adenocarcinoma.

Infographic showing OS improvement with nivolumab plus chemotherapy

Nivolumab (Opdivo, Bristol Myers Squibb) — a PD-1 inhibitor approved in the United States for treatment of several cancer types — is the first immunotherapy approved for first-line treatment of gastric cancer.

An estimated 28,000 new cases of gastric cancer are diagnosed each year in the United States. Approximately 5% of patients with advanced or metastatic disease survive 5 years.

Richard Pazdur
Richard Pazdur

“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,” Richard Pazdur, MD, director of 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, said in a press release.

The FDA based the approval in part on results of a randomized trial that included 1,581 patients with previously untreated advanced or metastatic gastric cancer, gastroesophageal junction cancer or esophageal adenocarcinoma. Researchers assigned 789 patients to nivolumab plus chemotherapy, and the other 792 patients received chemotherapy alone.

Results of the multicenter, open-label trial showed longer median survival among nivolumab-treated patients (13.8 months vs. 11.6 months).

The most common adverse events reported in the nivolumab-plus-chemotherapy group included peripheral neuropathy, nausea, fatigue, diarrhea, vomiting, decreased appetite, abdominal pain, constipation and musculoskeletal pain.

The FDA previously granted priority review and orphan drug designations to nivolumab for this indication.

The agency reviewed the application under Project Orbis, which provides a framework for concurrent submission and review of oncology drugs among international partners. Reviews are ongoing by regulatory agencies in Australia, Brazil, Canada and Switzerland.