Bristol-Myers granted European Commission approval for Opdivo in NSCLC

Bristol Myers announced that the European Commission has approved Opdivo – nivolumab – in combination with platinum-based chemotherapy for the neoadjuvant treatment of resectable non-small cell lung cancer, or NSCLC, at high risk of recurrence in adult patients with tumor cell PD-L1 expression greater than or equal to 1%. Opdivo with chemotherapy becomes the first neoadjuvant immunotherapy-based treatment option approved for patients in the European Union in this setting. The EC’s decision is based on results from the Phase 3 CheckMate -816 trial, in which three cycles of Opdivo with chemotherapy demonstrated a statistically significant and clinically meaningful improvement in event-free survival and pathologic complete response compared to chemotherapy alone when administered before surgery. The safety profile of Opdivo with chemotherapy was consistent with previously reported studies in NSCLC. Opdivo with chemotherapy has also been approved for the neoadjuvant treatment of patients with resectable NSCLC regardless of PD-L1 expression levels in 21 countries, including the United States, Japan and China, and additional regulatory applications are under review by global health authorities.