O Drug New Surprise: US FDA Approves Immunotherapy for First-line Treatment of Advanced Gastric Cancer for the First Time

April 16, the US Food and Drug Administration Bureau ( the FDA when) the approval of Bristol-Myers Squibb PD-1 monoclonal antibody inhibitors Carolina Wu (Opdivo, nivolumab) with certain types of chemotherapy used in combination, for advanced or metastaticInitial treatment of patients with gastric cancer , gastroesophageal junction cancer and esophageal adenocarcinoma.

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Dr.

In the United States, there are approximately 28,000 newly diagnosed gastric cancer patients each year .

Opdivo is a monoclonal antibody that inhibits tumor growth by enhancing T cell function.

The most common side effects of Opdivo combined with chemotherapy include peripheral neuropathy (damage to nerves outside the brain and spinal cord), nausea, fatigue, diarrhea, vomiting, loss of appetite, abdominal pain, constipation, and musculoskeletal pain.

Opdivo won the priority review and orphan drug designation for this indication.

The FDA approved Bristol-Myers Squibb's application.

Earlier in March 2020, Opdivo was officially approved by the National Medical Products Administration of China for the treatment of patients with advanced or recurrent gastric or gastroesophageal junction adenocarcinoma who had previously received two or more systemic treatment options.

The approval is based on a phase III clinical study called ATTRACTION-2, which is the world's first phase III clinical trial for the treatment of gastric cancer immuno-oncology.