Posted by Michael Wonder on 29 Mar 2022
European Medicines Agency validates Bristol Myers Squibb’s application for Opdivo (nivolumab) with chemotherapy as neo-adjuvant treatment for resectable non-small-cell lung cancer
29 March 2022 - Application based on CheckMate-816, the only Phase 3 trial to demonstrate improved event-free survival and pathologic complete response with an immunotherapy-based combination in the neo-adjuvant setting of non-small-cell lung cancer.
Bristol Myers Squibb today announced that the EMA has validated its type II variation application for Opdivo (nivolumab) in combination with chemotherapy for the neo-adjuvant treatment of patients with resectable stage IB to IIIA non-small-cell lung cancer, based on results from the CheckMate-816 trial.
