# Dabrafenib

Dabrafenib (Finlee, Tafinlar, 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 | + trametinib | Advanced | - |

### Melanoma

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

### Glioma

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| BRAF V600E | + trametinib | Any line | Low-grade glioma only; Children and adolescents only; Aged 1 year and older; require systemic therapy |
| BRAF V600E | + trametinib | 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 | + trametinib | 2nd line, advanced | Differentiated thyroid cancer only; After prior systemic therapy; Refractory to or not eligible for radioactive iodine (RAI) |

## Products

### Tafinlar

- Company: Novartis Europharm Limited
- Target: BRAF inhibitor
- Class: B-raf serine-threonine kinase (BRAF) inhibitors
- ATC: L01EC02
- EU approval: 26 Aug 2013
- Label revised: 19 May 2026
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/tafinlar-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/tafinlar-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/tafinlar

Mechanism (SmPC section 5.1): Dabrafenib inhibits RAF kinases, particularly BRAF with activating V600 mutations, suppressing ERK phosphorylation in the RAS/RAF/MEK/ERK pathway and inhibiting tumour cell growth.

### Finlee

- Company: Novartis Europharm Limited
- Target: BRAF inhibitor
- Class: B-raf serine-threonine kinase (BRAF) inhibitors
- ATC: L01EC02
- EU approval: 15 Nov 2023
- Label revised: 30 Mar 2026
- Status: orphan medicine
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/finlee-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/finlee-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/finlee

Mechanism (SmPC section 5.1): Dabrafenib inhibits RAF kinases, including mutant BRAF V600, blocking constitutive RAS/RAF/MEK/ERK signalling; it is used with the MEK inhibitor trametinib for dual pathway blockade.

## Label wording

- **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)
- **Dabrafenib** (Tafinlar), Non-small cell lung cancer, advanced: “Dabrafenib in combination with trametinib 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/tafinlar-epar-product-information_en.pdf)
- **Dabrafenib** (Tafinlar), Thyroid cancer, 2nd line, advanced: “Dabrafenib in combination with trametinib 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/tafinlar-epar-product-information_en.pdf)
- **Dabrafenib** (Finlee), Glioma, any line: “Finlee in combination with trametinib 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/finlee-epar-product-information_en.pdf)
- **Dabrafenib** (Finlee), Glioma, any line: “Finlee in combination with trametinib 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/finlee-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/dabrafenib