28 March 2025 - Recommendation based on Phase 3 CheckMate -77T trial showing significant event-free survival improvement when compared to neoadjuvant chemotherapy and placebo followed by surgery and adjuvant placebo.
Bristol Myers Squibb today announced that the CHMP of the EMA has recommended approval of Opdivo (nivolumab), in combination with platinum-based chemotherapy as neo-adjuvant treatment, followed by Opdivo as monotherapy as adjuvant treatment after surgical resection for the treatment of resectable non-small cell lung cancer at high risk of recurrence in adult patients whose tumours have PD-L1 expression ≥1%.