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 of adult patients with resectable non-small cell lung cancer at high risk of recurrence whose tumors haev PD-L1 expression >= 1%. This indication is based on CA209816, a randomized, open-label, phase 3 study where the selection of platinum-based chemotherapy was investigator's choice of paclitaxel and carboplatin, pemetrexed and cisplatin, or gemcitabine and cisplatin.

This is written in the approval document as:

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%.

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 March 2024. Accessed March 22, 2024.

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	Carboplatin, Nivolumab, Pemetrexed
Sensitivity (+)	PD-L1 >= 1%	Non-Small Cell Lung Cancer	Cisplatin, Gemcitabine, Nivolumab