EMA validates MAA for Opdivo as adjuvant treatment for resected esophageal or gastroesophageal junction cancer following chemoradiotherapy.- BMS

Bristol Myers Squibb announced that the European Medicines Agency (EMA) validated its Marketing Authorization Application (MAA) for Opdivo (nivolumab) as an adjuvant treatment for esophageal or gastroesophageal junction (GEJ) cancer in adult patients with residual pathologic disease after neoadjuvant chemoradiotherapy (CRT) and resection. Validation of the application confirms that submission is complete, and the EMA’s centralized review process will begin. The application is based on results from the Phase III CheckMate -577 trial, in which Opdivo doubled median disease-free survival (DFS) - its primary endpoint – in patients with esophageal or GEJ cancer, following neoadjuvant CRT and tumor resection. The safety profile of Opdivo as adjuvant therapy in the CheckMate -577 trial was consistent with that reported in previous Opdivo studies.