# Trametinib

Trametinib (Mekinist, Spexotras, Novartis Europharm Limited) has 7 EU-approved indications in 4 tumour types. Each needs a biomarker result: BRAF (7).

## Approved indications

### Non-small cell lung cancer

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| BRAF V600 | + dabrafenib | Advanced | - |

### Melanoma

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| BRAF V600 | + dabrafenib | Adjuvant, locally advanced | Following complete resection; Aged 12 years and older |
| BRAF V600 | + dabrafenib | Advanced | Aged 12 years and older |
| BRAF V600 | Monotherapy | Advanced | Aged 12 years and older |

### Glioma

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| BRAF V600E | + dabrafenib | Any line | Low-grade glioma only; Children and adolescents only; Aged 1 year and older; require systemic therapy |
| BRAF V600E | + dabrafenib | Any line | High-grade glioma only; Children and adolescents only; After at least one prior radiation and/or chemotherapy treatment; Aged 1 year and older |

### Thyroid cancer

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| BRAF V600E | + dabrafenib | 2nd line, advanced | Differentiated thyroid cancer only; Progressed during or after prior systemic therapy; Refractory to or not eligible for radioactive iodine (RAI) |

## Products

### Mekinist

- Company: Novartis Europharm Limited
- Target: MEK1/2 inhibitor
- Class: Mitogen-activated protein kinase (MEK) inhibitors
- ATC: L01EE01
- EU approval: 30 Jun 2014
- Label revised: 22 May 2026
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/mekinist-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/mekinist-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/mekinist

Mechanism (SmPC section 5.1): Reversible, highly selective allosteric inhibitor of MEK1 and MEK2 activation and kinase activity, blocking BRAF-driven signalling through the ERK pathway.

### Spexotras

- Company: Novartis Europharm Limited
- Target: MEK1/2 inhibitor
- Class: Mitogen-activated protein kinase (MEK) inhibitors
- ATC: L01EE01
- EU approval: 5 Jan 2024
- Label revised: 19 May 2026
- Status: orphan medicine
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/spexotras-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/spexotras-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/spexotras

Mechanism (SmPC section 5.1): Trametinib reversibly and allosterically inhibits MEK1 and MEK2 activation by BRAF and their kinase activity, blocking ERK pathway signalling; it is used with the RAF inhibitor dabrafenib.

## Label wording

- **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)
- **Trametinib** (Mekinist), Non-small cell lung cancer, advanced: “Trametinib in combination with dabrafenib is indicated for the treatment of adults with advanced non-small cell lung cancer with a BRAF V600 mutation.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/mekinist-epar-product-information_en.pdf)
- **Trametinib** (Mekinist), Thyroid cancer, 2nd line, advanced: “Trametinib in combination with dabrafenib is indicated for the treatment of adult patients with locally advanced or metastatic differentiated thyroid cancer with a BRAF V600E mutation, refractory to or not eligible for radioactive iodine (RAI) who have progressed during or after prior systemic therapy (for biomarker-based patient selection, see section 4.2).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/mekinist-epar-product-information_en.pdf)
- **Trametinib** (Spexotras), Glioma, any line: “Spexotras in combination with dabrafenib is indicated for the treatment of paediatric patients aged 1 year and older with low-grade glioma (LGG) with a BRAF V600E mutation who require systemic therapy.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/spexotras-epar-product-information_en.pdf)
- **Trametinib** (Spexotras), Glioma, any line: “Spexotras in combination with dabrafenib is indicated for the treatment of paediatric patients aged 1 year and older with high-grade glioma (HGG) with a BRAF V600E mutation who have received at least one prior radiation and/or chemotherapy treatment.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/spexotras-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/trametinib