Regulatory approval

Published by the European Medicines Agency. Approved

The European Medicines Agency (EMA) has authorized nivolumab in combination with ipilimumab and 2 cycles of platinum-based chemotherapy for the first-line treatment of adult patients with metastatic non-small cell lung cancer whose tumors have no sensitizing EGFR mutations or ALK translocations. This indication is based on CA2099LA, a phase 3, randomized, and open-label study in which the platinum-based chemotherapy was either carboplatin and pemetrexed or cisplatin and pemetrexed for non-squamous NSCLC, or carboplatin and paclitaxel for squamous NSCLC.

This is written in the approval document as:

OPDIVO in combination with ipilimumab and 2 cycles of platinum-based chemotherapy is indicated for the first-line treatment of metastatic non-small cell lung cancer in adults whose tumours have no sensitising EGFR mutation or ALK translocation.

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) Wild type ALK, Wild type EGFR Non-Small Cell Lung Cancer Carboplatin, Ipilimumab, Nivolumab, Pemetrexed
EMA (1) Wild type ALK, Wild type EGFR Non-Small Cell Lung Cancer Cisplatin, Ipilimumab, Nivolumab, Pemetrexed
EMA (1) Wild type ALK, Wild type EGFR Non-Small Cell Lung Cancer Carboplatin, Ipilimumab, Nivolumab, Paclitaxel

Contributions

Date Contributor Description
2024-10-20 Van Allen lab Adding EMA approvals for use to database
2020-11-05 European Medicines Agency Indication received approval from the European Commission.