Regulatory approval

Published by the European Medicines Agency. Approved

The European Medicines Agency (EMA) has authorized nivolumab in combination with platinum-based chemotherapy for the neoadjuvant treatment, followed by nivolumab as monotherapy as adjuvant treatment, of patients with resectable non-small cell lung cancer at high risk of recurrence whose tumors have PD-L1 expression >= 1%. This indication is based on CA20977T, randomised, double-blind study consisting of 461 patients. Platinum-based chemotherapy consisted of paclitaxel and carboplatin (any histology); pemetrexed and cisplatin (non-squamous histology); pemetrexed or carboplatin (non-squamous histology); or cisplatin and docetaxel (squamous histology).

This is written in the approval document as:

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%.

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, Nivolumab, Pemetrexed
EMA (1) PD-L1 >= 1% Non-Small Cell Lung Cancer Cisplatin, Docetaxel, Nivolumab

Contributions

Date Contributor Description
2025-09-04 Van Allen lab On 2025-06-02, the EMA published an EPAR - Assessment report - Variation for Opdivo (nivolumab) for that added an extension indication to nivolumab in combination with platinum-based chemotherapy for the neoadjuvant treatment, followed by nivolumab as monotherapy as adjuvant treatment, of patients with resectable non-small cell lung cancer at high risk of recurrence whose tumors have PD-L1 expression >= 1%.
2025-05-15 European Medicines Agency Indication received approval from the European Commission.