Regulatory approval

Published by the European Medicines Agency.

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.

Therapeutic response

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

Type	Biomarker(s)	Cancer type	Therapy(ies)
Sensitivity (+)	PD-L1 >= 1%	Non-Small Cell Lung Cancer	Carboplatin, Nivolumab, Paclitaxel
Sensitivity (+)	PD-L1 >= 1%	Non-Small Cell Lung Cancer	Cisplatin, Nivolumab, Pemetrexed
Sensitivity (+)	PD-L1 >= 1%	Non-Small Cell Lung Cancer	Carboplatin, Nivolumab, Pemetrexed
Sensitivity (+)	PD-L1 >= 1%	Non-Small Cell Lung Cancer	Cisplatin, Docetaxel, Nivolumab