Relatlimab + nivolumab

Relatlimab + nivolumab (Opdualag, Bristol-Myers Squibb Pharma EEIG) has 1 EU-approved indication in 1 tumour type. It needs a biomarker result: PD-L1 (1).
Approved indications of Relatlimab + nivolumab
Biomarker requirementRegimenSettingConditions
Melanoma1
PD-L1 TPS < 1%
Monotherapy
1L
advanced
Aged 12 years and older
Full text of section 4.1 (therapeutic indications)

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%.

Label history

6 changes to the Opdualag label since 2024, none of them to the indications. Newest first, in the words of EMA's record of each procedure.

Changes