# Vemurafenib

Vemurafenib (Zelboraf, Roche Registration GmbH) has 1 EU-approved indication in 1 tumour type. It needs a biomarker result: BRAF (1).

## Approved indications

### Melanoma

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| BRAF V600 | Monotherapy | Advanced | - |

## Products

### Zelboraf

- Company: Roche Registration GmbH
- Target: BRAF inhibitor
- Class: B-raf serine-threonine kinase (BRAF) inhibitors
- ATC: L01EC01
- EU approval: 17 Feb 2012
- Label revised: 19 Jun 2025
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/zelboraf-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/zelboraf-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/zelboraf

Mechanism (SmPC section 5.1): Inhibits BRAF serine-threonine kinase with activating codon 600 mutations, suppressing ERK phosphorylation and cellular proliferation.

## Label wording

- **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/drugs/vemurafenib