FDA accepts two sBLA filings for Opdivo in upper GI cancers

The US Food and Drug Administration has accepted and granted Priority Review for two supplemental Biologics License Applications (sBLAs) from Bristol Myers Squibb (NYSE: BMY) for Opdivo (nivolumab) in upper GI cancers.

The first is for Opdivo as a treatment of patients with resected esophageal or gastroesophageal junction (GEJ) cancer in the adjuvant setting, after neoadjuvant chemoradiation therapy (CRT). The FDA granted the application Priority Review and assigned a Prescription Drug User Fee Act (PDUFA) goal date of May 20, 2021.

“The FDA’s acceptance of our application marks important progress toward our goal of advancing treatment options for patients with esophageal or gastroesophageal junction cancer, in this case in early-stage disease,” said Dr Ian Waxman, development lead, gastrointestinal cancers, Bristol Myers Squib, adding: “We look forward to working with the FDA to potentially bring Opdivo to these patients, who face a critical unmet need and remain at high risk for disease recurrence.”