Posted by Michael Wonder on 05 Jan 2021
European Medicines Agency validates Bristol Myers Squibb’s application for Opdivo (nivolumab) as adjuvant treatment for resected oesophageal or gastro-oesophageal junction cancer following chemoradiotherapy
4 January 2021 - Bristol Myers Squibb today announced that the EMA validated its marketing authorisation application for Opdivo (nivolumab) as an adjuvant treatment for oesophageal or gastro-oesophageal junction cancer in adult patients with residual pathologic disease after neo-adjuvant chemoradiotherapy and resection.
The application is based on results from the Phase 3 CheckMate-577 trial, in which Opdivo doubled median disease-free survival - its primary outcome – in patients with oesophageal or GEJ cancer, following neo-adjuvant chemoradiotherapy and tumour resection.
