BMS’ Opdivo Wins FDA Nod for Stomach Cancer

The FDA has approved Bristol Myers Squibb’s blockbuster oncology drug Opdivo (nivolumab) for the treatment of patients with completely resected esophageal or gastroesophageal junction cancer who have residual pathologic disease and have received neoadjuvant chemoradiotherapy — making it the first immunotherapy to receive the agency’s blessing for this indication.

The approval of the monoclonal antibody therapy was supported by results from a phase 3 trial in 794 patients with residual disease. Participants who received the drug showed disease-free survival of 22.4 months, twice as long as those given a placebo.

The recommended treatment is 240 mg of Opdivo every two weeks or 480 mg every four weeks, administered via a 30-minute intravenous infusion for a total of one year, the agency said.

Opdivo earned global revenue of almost $7 billion in 2020. The drug has a total of 22 indications in the U.S., across 11 different cancer types. It has no biosimilar treatment option.