Regulatory approval

Published by the European Medicines Agency. Approved

OPDIVO in combination with platinum-based chemotherapy as neoadjuvant treatment, followed by OPDIVO as monotherapy as adjuvant treatment, is indicated for the treatment of resectable non-small cell lung cancer at high risk of recurrence in adult patients whose tumors have PD-L1 expression >= 1%.

This is written in the approval document.

Citation

Bristol-Myers Squibb Pharma EEIG. Opdivo (nivolumab) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/opdivo-epar-product-information_en.pdf. Revised June 2025. Accessed September 5, 2025.

Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

Organizations	Biomarkers	Cancer types	Therapies
EMA (1)	PD-L1 >= 1%	Non-Small Cell Lung Cancer	Carboplatin, Nivolumab, Paclitaxel
EMA (1)	PD-L1 >= 1%	Non-Small Cell Lung Cancer	Carboplatin, Nivolumab, Pemetrexed
EMA (1)	PD-L1 >= 1%	Non-Small Cell Lung Cancer	Cisplatin, Nivolumab, Pemetrexed
EMA (1)	PD-L1 >= 1%	Non-Small Cell Lung Cancer	Cisplatin, Docetaxel, Nivolumab