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Opdivo Plus Chemotherapy Approved for Treatment of Gastric Cancer

TUESDAY, April 20, 2021 -- Opdivo (nivolumab) is now approved for the treatment of advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma, the U.S. Food and Drug Administration announced Friday.

The agency approved Opdivo in combination with fluoropyrimidine- and platinum-containing chemotherapy -- making it the first FDA-approved immunotherapy for the first-line treatment of gastric cancer.

Approval of Opdivo for this indication was based on data from the Phase 3 CheckMate-649 trial, a randomized, multicenter, open-label trial of 1,581 patients with previously untreated advanced or metastatic gastric cancer, esophageal junction cancer, and esophageal adenocarcinoma. The researchers randomly assigned 789 patients to Opdivo combined with mFOLFOX6 (fluorouracil, leucovorin, and oxaliplatin) or CapeOX (capecitabine and oxaliplatin) and 792 to chemotherapy alone (mFOLFOX6 or CapeOX). Median survival was 13.8 and 11.6 months for patients who received Opdivo and chemotherapy and those who received chemotherapy alone, respectively. In an exploratory analysis, the researchers found that 55 percent of patients who received Opdivo plus chemotherapy versus 48 percent who received chemotherapy alone were alive at one year.

The most commonly reported side effects with Opdivo combined with chemotherapy were peripheral neuropathy, nausea, fatigue, diarrhea, vomiting, decreased appetite, abdominal pain, constipation, and musculoskeletal pain. Potential serious conditions that can be caused by Opdivo include immune-mediated side effects like pneumonitis, colitis, hepatitis, endocrinopathies, and nephritis.

Approval was granted to the Bristol-Myers Squibb Company.

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