Regulatory approval

Published by the European Medicines Agency. Approved

OPDIVO in combination with platinum-based chemotherapy is indicated for the neoadjuvant treatment of resectable non-small cell lung cancer at high risk of recurrence in adult patients whose tumours 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.

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Therapeutic response

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

Organizations
Biomarkers
Cancer types
Therapies
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, Gemcitabine, Nivolumab

Contributions

Date Contributor Description
2024-10-20 Van Allen lab Adding EMA approvals for use to database
2023-06-26 European Medicines Agency Indication received approval from the European Commission.