Regulatory approval

Published by the European Medicines Agency.

The European Medicines Agency (EMA) has authorized Opdualag (relatlimab / nivolumab) for the first-line treatment of adults and adolescents 12 years of age and older with advanced (unresectable or metastatic) melanoma with tumor cell PD-L1 expression < 1%.

This is written in the approval document as:

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%.

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.

Type	Biomarker(s)	Cancer type	Therapy(ies)
Sensitivity (+)	PD-L1 < 1%	Melanoma	Nivolumab, Relatlimab