Therapeutic Response Statement (Sensitivity)

This therapeutic response statement Supports the relationship that PD-L1 >= 1% status confers therapeutic sensitivity to Cisplatin, Fluorouracil, Nivolumab in patients with Esophageal Squamous Cell Carcinoma.

The European Medicines Agency (EMA) has authorized nivolumab in combination with fluoropyrimidine- and platinum-based combination chemotherapy for the first-line treatment of adult patients with unresectable, advanced, or recurrent metastatic esophageal squamous cell carcinoma with tumor cell PD-L1 expression >= 1%. This indication is based on CA209648, a randomized, active-controlled, and open-label study where the choice of chemotherapy was fluorouracil and cisplatin.

This statement is based on a regulatory approval from the European Medicines Agency:

OPDIVO in combination with fluoropyrimidine- and platinum-based combination chemotherapy is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell 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.

Contributions

Date	Contributor	Description
2024-10-20	Van Allen lab	Adding EMA approvals for use to database
2022-04-01	European Medicines Agency	Indication received approval from the European Commission.