Regulatory approval

Published by the European Medicines Agency. Approved

OPDIVO in combination with fluoropyrimidine- and platinum-based combination chemotherapy is indicated for the first-line treatment of adult patients with HER2-negative advanced or metastatic gastric, gastro-oesophageal junction or oesophageal adenocarcinoma whose tumours express PD-L1 with a combined positive score (CPS) >= 5.

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.

Therapeutic response

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

Organizations	Biomarkers	Cancer types	Therapies
EMA (1)	HER2-negative, PD-L1 (CPS) >= 5	Esophageal Adenocarcinoma	Fluorouracil, Nivolumab, Oxaliplatin
EMA (1)	HER2-negative, PD-L1 (CPS) >= 5	Adenocarcinoma of the Gastroesophageal Junction	Fluorouracil, Nivolumab, Oxaliplatin
EMA (1)	HER2-negative, PD-L1 (CPS) >= 5	Stomach Adenocarcinoma	Capecitabine, Nivolumab, Oxaliplatin
EMA (1)	HER2-negative, PD-L1 (CPS) >= 5	Adenocarcinoma of the Gastroesophageal Junction	Capecitabine, Nivolumab, Oxaliplatin
EMA (1)	HER2-negative, PD-L1 (CPS) >= 5	Esophageal Adenocarcinoma	Capecitabine, Nivolumab, Oxaliplatin
EMA (1)	HER2-negative, PD-L1 (CPS) >= 5	Stomach Adenocarcinoma	Fluorouracil, Nivolumab, Oxaliplatin

Contributions

Date	Contributor	Description
2024-10-20	Van Allen lab	Adding EMA approvals for use to database
2021-10-19	European Medicines Agency	Indication received approval from the European Commission.