New Opdivo Indication Approved for Gastrointestinal Cancers

April 16, 2021 – The U.S. FDA has approved a new indication for Opdivo® (nivolumab), manufactured by Bristol Myers Squibb. The drug is now indicated for use in combination with fluoropyrimidine - and platinum-containing chemotherapy to treat advanced or metastatic gastric cancer, gastroesophageal junction (GEJ) cancer, and esophageal adenocarcinoma. Because this new indication was granted accelerated approval, continued approval may be contingent upon verification and description of clinical benefit in confirmatory trials.

Gastric cancer, GEJ cancer, and esophageal adenocarcinoma affect portions of the upper gastrointestinal (GI) system. Gastric cancer affects the stomach, while GEJ affects the area where the stomach joins the esophagus – a tube that connects the throat to the stomach. GEJ cancer and esophageal cancers like esophageal adenocarcinoma are frequently similar and treated in a similar manner. For patients whose upper GI cancer has spread (metastasized), the prognosis is often poor with five -year survival rates in the single digits.

In a clinical trial, Opdivo plus chemotherapy reduced the risk of death by 20% compared to chemotherapy alone. In addition, 55% of patients on Opdivo plus chemotherapy were alive at one year, compared to 48% of patients on chemotherapy alone.

Recommended dosing under the new indication is a 30-minute intravenous infusion of Opdivo with fluoropyrimidine- and platinum-containing chemotherapy, on a schedule of either 240mg of Opdivo administered once every two weeks or 360mg of Opdivo administered once every three weeks. The recommended duration of therapy is until disease progression or unacceptable toxicity occur, or up to two years.

Originally FDA approved in 2014, Opdivo has more than a dozen indications to treat cancer either alone or in combination with other therapies.