# Vismodegib

Vismodegib (Erivedge, Roche Registration GmbH) has 2 EU-approved indications in 1 tumour type.

## Approved indications

### Basal cell carcinoma

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| None | Monotherapy | Metastatic | Symptomatic |
| None | Monotherapy | Locally advanced | Inappropriate for surgery or radiotherapy |

## Products

### Erivedge

- Company: Roche Registration GmbH
- Target: Hedgehog pathway inhibitor
- Class: Other antineoplastic agents
- ATC: L01XX43
- EU approval: 12 Jul 2013
- Label revised: 5 Nov 2025
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/erivedge-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/erivedge-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/erivedge

Mechanism (SmPC section 5.1): Vismodegib binds to and inhibits the Smoothened transmembrane protein, blocking Hedgehog pathway signal transduction.

## Label wording

- **Vismodegib** (Erivedge), Basal cell carcinoma, metastatic: “Erivedge is indicated for the treatment of adult patients with: symptomatic metastatic basal cell carcinoma locally advanced basal cell carcinoma inappropriate for surgery or radiotherapy (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/erivedge-epar-product-information_en.pdf)
- **Vismodegib** (Erivedge), Basal cell carcinoma, locally advanced: “Erivedge is indicated for the treatment of adult patients with: symptomatic metastatic basal cell carcinoma locally advanced basal cell carcinoma inappropriate for surgery or radiotherapy (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/erivedge-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/vismodegib