# Sorafenib

Sorafenib (Nexavar, Bayer AG) has 3 EU-approved indications in 3 tumour types.

## Approved indications

### Hepatocellular carcinoma

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| None | Monotherapy | Any line | - |

### Renal cell carcinoma

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| None | Monotherapy | Advanced | Failed prior interferon-alpha or interleukin-2 based therapy, or considered unsuitable for such therapy |

### Thyroid cancer

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| None | Monotherapy | Advanced | Differentiated thyroid cancer only; Progressive; refractory to radioactive iodine |

## Products

### Nexavar

- Company: Bayer AG
- Target: Multikinase inhibitor (RAF, VEGFR, PDGFR)
- Class: Other protein kinase inhibitors
- ATC: L01EX02
- EU approval: 19 Jul 2006
- Label revised: 28 Mar 2025
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/nexavar-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/nexavar-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/nexavar
- Biosimilars and generics: Sorafenib Accord

Mechanism (SmPC section 5.1): Sorafenib inhibits RAF serine/threonine kinases (CRAF, BRAF incl. V600E) and receptor tyrosine kinases (KIT, FLT3, VEGFR-2/3, PDGFR-β), reducing tumour-cell proliferation and tumour angiogenesis.

## Label wording

- **Sorafenib** (Nexavar), Hepatocellular carcinoma, any line: “Nexavar is indicated for the treatment of hepatocellular carcinoma (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/nexavar-epar-product-information_en.pdf)
- **Sorafenib** (Nexavar), Renal cell carcinoma, advanced: “Nexavar is indicated for the treatment of patients with advanced renal cell carcinoma who have failed prior interferon-alpha or interleukin-2 based therapy or are considered unsuitable for such therapy.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/nexavar-epar-product-information_en.pdf)
- **Sorafenib** (Nexavar), Thyroid cancer, advanced: “Nexavar is indicated for the treatment of patients with progressive, locally advanced or metastatic, differentiated (papillary/follicular/Hürthle cell) thyroid carcinoma, refractory to radioactive iodine.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/nexavar-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/sorafenib