29 June 2023 - Approval based on results from Phase 3 CheckMate-816 trial showing that neo-adjuvant Opdivo with chemotherapy improved event-free survival and pathologic complete response compared to chemotherapy alone.
Bristol Myers Squibb today announced that the European Commission has approved Opdivo (nivolumab) in combination with platinum-based chemotherapy for the neo-adjuvant treatment of resectable non-small cell lung cancer at high risk of recurrence in adult patients with tumour cell PD-L1 expression ≥1%.