# 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

### Melanoma

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| PD-L1 TPS < 1% | Monotherapy | 1st line, advanced | Aged 12 years and older |

## Products

### Opdualag

- Company: Bristol-Myers Squibb Pharma EEIG
- Target: PD-1 and LAG-3 checkpoint inhibitor combination
- Class: Combinations of monoclonal antibodies and antibody drug conjugates
- ATC: L01FY02
- EU approval: 15 Sep 2022
- Label revised: 21 Jul 2026
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/opdualag-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/opdualag-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/opdualag

Mechanism (SmPC section 5.1): Binds PD-1 and LAG-3 receptors to block interaction with their ligands, reducing inhibitory signalling and enhancing T-cell activation and anti-tumour immune responses.

## Label wording

- **Relatlimab + nivolumab** (Opdualag), Melanoma, 1st line, advanced: “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%.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/opdualag-epar-product-information_en.pdf)

Source: section 4.1 of each summary of product characteristics (SmPC), EMA data as of 5 Nov 2026. AI models structured these entries and no person has checked them yet. oncolabels is a non-commercial reference for education and research and gives no medical advice; the current SmPC takes precedence.

Data under CC BY 4.0: credit oncolabels and the European Medicines Agency. Page: https://oncolabels.com/drugs/relatlimab-nivolumab