FDA accepts sBLA for Opdivo combined with chemotherapy for treatment of gastric cancer, gastroesophageal junction cancer and esophageal adenocarcinoma.- BMS

Bristol Myers Squibb announced that the FDA has accepted its supplemental Biologics License Application (sBLA) for Opdivo (nivolumab), in combination with fluoropyrimidine- and platinum-containing chemotherapy, for the treatment of patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer (GEJC) or esophageal adenocarcinoma (EAC), based on results from the CheckMate -649 trial. The FDA granted the application Priority Review and assigned a Prescription Drug User Fee Act (PDUFA) goal date of May 25, 2021. The filing was based on results from the pivotal Phase III CheckMate -649 trial, which showed that first-line treatment with Opdivo plus leucovorin, 5-fluorouracil and oxaliplatin (FOLFOX) or capecitabine and oxaliplatin (CapeOX) led to a statistically significant improvement in overall survival (OS) and progression-free survival (PFS) for patients with unresectable advanced or metastatic gastric cancer, GEJC or EAC whose tumors express PD-L1 with a combined positive score (CPS) greater than 5, compared to treatment with chemotherapy alone. A statistically significant OS benefit was also observed in the all-randomized population. The safety profile of Opdivo plus chemotherapy was consistent with the known safety profile of the individual treatments. To date, CheckMate -649 is the largest randomized, global Phase III study of an immune checkpoint inhibitor-based therapy for patients with gastric cancer, GEJC and EAC..