Regulatory approval

Published by the European Medicines Agency. Approved

Opdualag is indicated for the first-line treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and older with tumour cell PD-L1 expression < 1%.

This is written in the approval document.

Citation

Bristol-Myers Squibb Pharma EEIG. Opdualag (relatlimab / nivolumab) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/opdualag-epar-product-information_en.pdf. Revised February 2024. Accessed March 22, 2024.

Therapeutic response

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

Organizations	Biomarkers	Cancer types	Therapies
EMA (1)	PD-L1 < 1%	Melanoma	Nivolumab, Relatlimab

Contributions

Date	Contributor	Description
2024-10-20	Van Allen lab	Adding EMA approvals for use to database
2022-09-15	European Medicines Agency	Indication received approval from the European Commission.