Regulatory approval

Published by the European Medicines Agency.

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 is written in the approval document as:

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 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%	Esophageal Squamous Cell Carcinoma	Cisplatin, Fluorouracil, Nivolumab