Posted by Michael Wonder on 20 Jan 2021
U.S. FDA accepts for priority review application for Opdivo (nivolumab) combined with chemotherapy as first-line treatment in metastatic gastric cancer, gastro-oesophageal junction cancer and oesophageal adenocarcinoma
20 January 2021 - U.S. FDA assigned a target action date of 25 May 2021.
Bristol Myers Squibb today announced that the U.S. FDA has accepted its supplemental biologics license application for Opdivo (nivolumab), in combination with fluoropyrimidine- and platinum-containing chemotherapy, for the treatment of patients with advanced or metastatic gastric cancer, gastro-oesophageal junction cancer or oesophageal adenocarcinoma, based on results from the CheckMate-649 trial.
The FDA granted the application priority review and assigned a Prescription Drug User Fee Act goal date of 25 May 2021.
