Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that PD-L1 < 1% status confers therapeutic sensitivity to Nivolumab, Relatlimab in patients with Melanoma.
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 statement is based on a regulatory approval from the European Medicines Agency:
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%.