# Regorafenib

Regorafenib (Stivarga, Bayer Pharma AG) has 3 EU-approved indications in 3 tumour types.

## Approved indications

### Gastrointestinal stromal tumour

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| None | Monotherapy | 3rd line+, advanced | Progressed on or are intolerant to prior treatment with imatinib and sunitinib |

### Colorectal cancer

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| None | Monotherapy | Metastatic | Previously treated with, or are not considered candidates for, available therapies (including fluoropyrimidine-based chemotherapy, an anti-VEGF therapy and an anti-EGFR therapy) |

### Hepatocellular carcinoma

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| None | Monotherapy | 2nd line | Previously treated with sorafenib |

## Products

### Stivarga

- Company: Bayer Pharma AG
- Target: Multikinase inhibitor (VEGFR, TIE2, KIT, RET)
- Class: Other protein kinase inhibitors
- ATC: L01EX05
- EU approval: 26 Aug 2013
- Label revised: 24 Mar 2026
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/stivarga-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/stivarga-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/stivarga

Mechanism (SmPC section 5.1): Oral multikinase inhibitor blocking angiogenic (VEGFR1-3, TIE2), oncogenic (KIT, RET, RAF), metastatic (PDGFR, FGFR) and immune (CSF1R) kinases; inhibits mutated KIT to block tumour-cell proliferation.

## Label wording

- **Regorafenib** (Stivarga), Colorectal cancer, metastatic: “- metastatic colorectal cancer (CRC) who have been previously treated with, or are not considered candidates for, available therapies. These include fluoropyrimidine-based chemotherapy, an anti-VEGF therapy and an anti-EGFR therapy (see section 5.1)” [SmPC](https://www.ema.europa.eu/en/documents/product-information/stivarga-epar-product-information_en.pdf)
- **Regorafenib** (Stivarga), Gastrointestinal stromal tumour, 3rd line+, advanced: “- unresectable or metastatic gastrointestinal stromal tumours (GIST) who progressed on or are intolerant to prior treatment with imatinib and sunitinib” [SmPC](https://www.ema.europa.eu/en/documents/product-information/stivarga-epar-product-information_en.pdf)
- **Regorafenib** (Stivarga), Hepatocellular carcinoma, 2nd line: “- hepatocellular carcinoma (HCC) who have been previously treated with sorafenib.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/stivarga-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/regorafenib