Posted by Michael Wonder on 05 Jan 2021
European Medicines Agency validates Bristol Myers Squibb’s application for Opdivo (nivolumab) combined with chemotherapy as first-line treatment in metastatic gastric cancer, gastro-oesophageal junction cancer and oesophageal adenocarcinoma
4 January 2021 - Bristol Myers Squibb today announced that the EMA validated its Type II Variation marketing authorisation application for Opdivo (nivolumab) in combination with fluoropyrimidine- and platinum-based combination chemotherapy for the first-line treatment of adult patients with advanced or metastatic gastric cancer, gastro-oesophageal junction cancer or oesophageal adenocarcinoma.
The filing is based on results from the pivotal Phase 3 CheckMate-649 trial, in which first-line treatment with Opdivo plus leucovorin, 5-fluorouracil and oxaliplatin or capecitabine and oxaliplatin was compared to treatment with chemotherapy alone.
