Posted by Michael Wonder on 20 Jan 2021
U.S. Food and Drug Administration accepts for priority review application for Opdivo (nivolumab) as adjuvant therapy for patients with resected oesophageal or gastro-oesophageal junction cancer
20 January 2021 - Application based on Phase 3 CheckMate-577 trial, in which Opdivo doubled median disease-free survival versus placebo in patients with oesophageal or gastro-oesophageal junction cancer following neo-adjuvant chemoradiation therapy and surgery.
Bristol Myers Squibb today announced that the U.S. FDA has accepted its supplemental biologics license application for Opdivo (nivolumab) for the treatment of patients with resected oesophageal or gastro-oesophageal junction cancer in the adjuvant setting, after neo-adjuvant chemoradiation therapy.
The FDA granted the application priority review and assigned a Prescription Drug User Fee Act goal date of 20 May 2021.
