# Melanoma

The EU has approved 19 indications of 11 drugs in melanoma. 11 of them need a biomarker result: BRAF (10) and PD-L1 (1). 6 tumour-agnostic approvals also apply when the tumour carries the alteration.

## Approved indications

### BRAF mutation

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Dabrafenib](https://oncolabels.com/drugs/dabrafenib) (Tafinlar) | BRAF V600 | + trametinib | Adjuvant, locally advanced | After complete resection; Aged 12 years and older |
| [Trametinib](https://oncolabels.com/drugs/trametinib) (Mekinist) | BRAF V600 | + dabrafenib | Adjuvant, locally advanced | Following complete resection; Aged 12 years and older |
| [Binimetinib](https://oncolabels.com/drugs/binimetinib) (Mektovi) | BRAF V600 | + encorafenib | Advanced | - |
| [Cobimetinib](https://oncolabels.com/drugs/cobimetinib) (Cotellic) | BRAF V600 | + vemurafenib | Advanced | - |
| [Dabrafenib](https://oncolabels.com/drugs/dabrafenib) (Tafinlar) | BRAF V600 | + trametinib | Advanced | Aged 12 years and older |
| [Dabrafenib](https://oncolabels.com/drugs/dabrafenib) (Tafinlar) | BRAF V600 | Monotherapy | Advanced | Aged 12 years and older |
| [Encorafenib](https://oncolabels.com/drugs/encorafenib) (Braftovi) | BRAF V600 | + binimetinib | Advanced | - |
| [Trametinib](https://oncolabels.com/drugs/trametinib) (Mekinist) | BRAF V600 | + dabrafenib | Advanced | Aged 12 years and older |
| [Trametinib](https://oncolabels.com/drugs/trametinib) (Mekinist) | BRAF V600 | Monotherapy | Advanced | Aged 12 years and older |
| [Vemurafenib](https://oncolabels.com/drugs/vemurafenib) (Zelboraf) | BRAF V600 | Monotherapy | Advanced | - |

### PD-L1

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Relatlimab + nivolumab](https://oncolabels.com/drugs/relatlimab-nivolumab) (Opdualag) | PD-L1 TPS < 1% | Monotherapy | 1st line, advanced | Aged 12 years and older |

### No biomarker required

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Nivolumab](https://oncolabels.com/drugs/nivolumab) (Opdivo) | None | Monotherapy | Adjuvant | After complete resection; Stage IIB or IIC melanoma, or melanoma with involvement of lymph nodes or metastatic disease |
| [Pembrolizumab](https://oncolabels.com/drugs/pembrolizumab) (Keytruda) | None | Monotherapy | Adjuvant | After complete resection; Stage IIB, IIC or III |
| [Ipilimumab](https://oncolabels.com/drugs/ipilimumab) (Yervoy) | None | + nivolumab | Advanced | - |
| [Ipilimumab](https://oncolabels.com/drugs/ipilimumab) (Yervoy) | None | Monotherapy | Advanced | - |
| [Nivolumab](https://oncolabels.com/drugs/nivolumab) (Opdivo) | None | + ipilimumab | Advanced | - |
| [Nivolumab](https://oncolabels.com/drugs/nivolumab) (Opdivo) | None | Monotherapy | Advanced | - |
| [Pembrolizumab](https://oncolabels.com/drugs/pembrolizumab) (Keytruda) | None | Monotherapy | Advanced | - |
| [Talimogene laherparepvec](https://oncolabels.com/drugs/talimogene-laherparepvec) (Imlygic) | None | Monotherapy | Advanced | Unresectable; Stage IIIB, IIIC and IVM1a; no bone, brain, lung or other visceral disease |

## Tumour-agnostic approvals

Approved for any solid tumour that carries the alteration, wherever the tumour started.

### EpCAM

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Catumaxomab](https://oncolabels.com/drugs/catumaxomab) (Korjuny) | EpCAM-positive | Monotherapy | 2nd line | Malignant ascites; not eligible for further systemic anticancer therapy Ambiguous in the label (tumour site, line of therapy): check the SmPC. |

### HER2

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Trastuzumab deruxtecan](https://oncolabels.com/drugs/trastuzumab-deruxtecan) (Enhertu) | HER2-positive (IHC 3+) | Monotherapy | 2nd line, advanced | After prior treatment; No satisfactory treatment options |

### NTRK fusion

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Entrectinib](https://oncolabels.com/drugs/entrectinib) (Rozlytrek) | NTRK fusion | Monotherapy | Any line | No prior NTRK inhibitor; Older than 1 month; disease that is locally advanced, metastatic or where surgical resection is likely to result in severe morbidity; no satisfactory treatment options |
| [Larotrectinib](https://oncolabels.com/drugs/larotrectinib) (Vitrakvi) | NTRK fusion | Monotherapy | Any line | Locally advanced, metastatic or where surgical resection is likely to result in severe morbidity; no satisfactory treatment options |
| [Repotrectinib](https://oncolabels.com/drugs/repotrectinib) (Augtyro) | NTRK fusion | Monotherapy | Advanced | Prior NTRK inhibitor, or no prior NTRK inhibitor and treatment options not targeting NTRK provide limited clinical benefit or have been exhausted; Aged 12 years and older |

### RET fusion

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Selpercatinib](https://oncolabels.com/drugs/selpercatinib) (Retsevmo) | RET fusion | Monotherapy | Advanced | Treatment options not targeting RET provide limited clinical benefit, or have been exhausted; Aged 2 years and older |

## Label wording

- **Pembrolizumab** (Keytruda), Melanoma, advanced: “KEYTRUDA as monotherapy is indicated for the treatment of adults and adolescents aged 12 years and older with advanced (unresectable or metastatic) melanoma.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/keytruda-epar-product-information_en.pdf)
- **Pembrolizumab** (Keytruda), Melanoma, adjuvant: “KEYTRUDA as monotherapy is indicated for the adjuvant treatment of adults and adolescents aged 12 years and older with Stage IIB, IIC or III melanoma and who have undergone complete resection (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/keytruda-epar-product-information_en.pdf)
- **Nivolumab** (Opdivo), Melanoma, adjuvant: “OPDIVO as monotherapy is indicated for the adjuvant treatment of adults and adolescents 12 years of age and older with Stage IIB or IIC melanoma, or melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/opdivo-epar-product-information_en.pdf)
- **Nivolumab** (Opdivo), Melanoma, advanced: “OPDIVO as monotherapy or in combination with ipilimumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and older.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/opdivo-epar-product-information_en.pdf)
- **Nivolumab** (Opdivo), Melanoma, advanced: “OPDIVO as monotherapy or in combination with ipilimumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and older.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/opdivo-epar-product-information_en.pdf)
- **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)
- **Encorafenib** (Braftovi), Melanoma, advanced: “Encorafenib in combination with binimetinib is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/braftovi-epar-product-information_en.pdf)
- **Ipilimumab** (Yervoy), Melanoma, advanced: “YERVOY as monotherapy or in combination with nivolumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and older (see section 4.4).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/yervoy-epar-product-information_en.pdf)
- **Ipilimumab** (Yervoy), Melanoma, advanced: “YERVOY as monotherapy or in combination with nivolumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and older (see section 4.4).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/yervoy-epar-product-information_en.pdf)
- **Trametinib** (Mekinist), Melanoma, advanced: “Trametinib as monotherapy or in combination with dabrafenib is indicated for the treatment of adults and adolescents aged 12 years and older with unresectable or metastatic melanoma with a BRAF V600 mutation (see sections 4.4 and 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/mekinist-epar-product-information_en.pdf)
- **Trametinib** (Mekinist), Melanoma, advanced: “Trametinib as monotherapy or in combination with dabrafenib is indicated for the treatment of adults and adolescents aged 12 years and older with unresectable or metastatic melanoma with a BRAF V600 mutation (see sections 4.4 and 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/mekinist-epar-product-information_en.pdf)
- **Trametinib** (Mekinist), Melanoma, adjuvant, locally advanced: “Trametinib in combination with dabrafenib is indicated for the adjuvant treatment of adults and adolescents aged 12 years and older with Stage III melanoma with a BRAF V600 mutation, following complete resection.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/mekinist-epar-product-information_en.pdf)
- **Dabrafenib** (Tafinlar), Melanoma, advanced: “Dabrafenib as monotherapy or in combination with trametinib is indicated for the treatment of adults and adolescents aged 12 years and older with unresectable or metastatic melanoma with a BRAF V600 mutation (see sections 4.4 and 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/tafinlar-epar-product-information_en.pdf)
- **Dabrafenib** (Tafinlar), Melanoma, advanced: “Dabrafenib as monotherapy or in combination with trametinib is indicated for the treatment of adults and adolescents aged 12 years and older with unresectable or metastatic melanoma with a BRAF V600 mutation (see sections 4.4 and 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/tafinlar-epar-product-information_en.pdf)
- **Dabrafenib** (Tafinlar), Melanoma, adjuvant, locally advanced: “Dabrafenib in combination with trametinib is indicated for the adjuvant treatment of adults and adolescents aged 12 years and older with Stage III melanoma with a BRAF V600 mutation, following complete resection.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/tafinlar-epar-product-information_en.pdf)
- **Talimogene laherparepvec** (Imlygic), Melanoma, advanced: “Imlygic is indicated for the treatment of adults with unresectable melanoma that is regionally or distantly metastatic (Stage IIIB, IIIC and IVM1a) with no bone, brain, lung or other visceral disease (see sections 4.4 and 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/imlygic-epar-product-information_en.pdf)
- **Binimetinib** (Mektovi), Melanoma, advanced: “Binimetinib in combination with encorafenib is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/mektovi-epar-product-information_en.pdf)
- **Cobimetinib** (Cotellic), Melanoma, advanced: “Cotellic is indicated for use in combination with vemurafenib for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation (see sections 4.4 and 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/cotellic-epar-product-information_en.pdf)
- **Vemurafenib** (Zelboraf), Melanoma, advanced: “Vemurafenib is indicated in monotherapy for the treatment of adult patients with BRAF V600 mutation-positive unresectable or metastatic melanoma (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/zelboraf-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/tumours/melanoma