Bristol Myers’ Opdivo Receives FDA Approval for Gastric Cancer

The U.S. Food and Drug Administration (FDA) recently approved Bristol Myers Squibb’s Opdivo for the initial treatment of certain types of cancer.

Opdivo, the trade name for the generic Nivolumab, can now be used in combination with certain types of chemotherapy for initial treatment of advanced or metastatic gastric cancer, gastroesophageal junction cancer and esophageal adenocarcinoma.

Opdivo is a targeted therapy that inhibits tumor growth by enhancing T-cell function. Specifically, as a human immunoglobulin G4 monoclonal antibody, it binds to programmed cell death protein 1 (PD-1) receptors found on T cells and blocks the interaction with PD-L1 and PD-L2. This, in turn, releases PD-1 pathway-mediated inhibition of the immune response, resulting in decreased tumor growth.

The FDA granted approval for Opdivo after Priority Review and Orphan Drug designations. The FDA said Opdivo received these designations because, if approved, it would provide, “significant improvements in the safety or effectiveness of the treatment, diagnosis or prevention of serious conditions when compared to standard applications.”

According to the FDA, the U.S. sees about 28,000 new diagnoses of gastric cancer every year. The current survival rate for all stages is 32% and the 5-year survival rate for or metastatic gastric cancer is 5%.

In a randomized, multicenter, open-label trial of 1,581 patients, the 789 patients who received Opdivo in combination with chemotherapy, on average, lived longer than the 792 patients who received chemotherapy alone.

“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, M.D., 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 collaborated with the Australian Therapeutic Goods Administration, the Brazilian Health Regulatory Agency, Health Canada and Switzerland’s Swissmedic for the review as part of Project Orbis. Project Orbis is an initiative of the FDA Oncology Center of Excellence to review and submit oncology drugs among international partners.

While promising, this treatment does not come without the risk of serious side effects. Opdivo can cause serious immune-mediated side effects, including inflammation of healthy organs and other common side effects 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 is provided to patients via 30 minute IV infusions in either 240mg doses every 2 weeks or 480mg every 4 weeks. Dosing schedules based on monotherapy indications can be found on the Obdivo website.