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Bristol Myers Squibb Receives European Commission Approval for Opdivo (nivolumab) with Chemotherapy as Neoadjuvant Treatment of Resectable Non-Small Cell Lung Cancer at High Risk of Recurrence in Patients with Tumor Cell PD-L1 Expression ≥1%

Approval based on results from Phase 3 CheckMate -816 trial showing that neoadjuvant Opdivo with chemotherapy improved event-free survival and pathologic complete response compared to chemotherapy alone


Opdivo with chemotherapy is now the first and only neoadjuvant immunotherapy-based treatment option approved to treat patients with non-small cell lung cancer in the European Union


This decision marks the fourth tumor type in which Opdivo-based regimens have been approved for use in earlier stages of cancer in the European Union, following melanoma, esophageal/gastroesophageal junction cancer and urothelial carcinoma ....

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