# Sunitinib

Sunitinib (Sutent, Pfizer Limited) has 3 EU-approved indications in 3 tumour types.

## Approved indications

### Gastrointestinal stromal tumour

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| None | Monotherapy | 2nd line, advanced | After imatinib treatment (failure due to resistance or intolerance) |

### Neuroendocrine tumours

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| None | Monotherapy | Advanced | Well-differentiated pancreatic NET only; Disease progression |

### Renal cell carcinoma

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| None | Monotherapy | Advanced | - |

## Products

### Sutent

- Company: Pfizer Limited
- Target: Multikinase inhibitor (VEGFR, PDGFR, KIT)
- Class: Other protein kinase inhibitors
- ATC: L01EX01
- EU approval: 19 Jul 2006
- Label revised: 10 Mar 2025
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/sutent-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/sutent-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/sutent
- Biosimilars and generics: Sunitinib Accord

Mechanism (SmPC section 5.1): Sunitinib inhibits multiple receptor tyrosine kinases, including PDGFR, VEGFR, KIT, and FLT3, to impair tumor growth, neoangiogenesis, and metastatic progression.

## Label wording

- **Sunitinib** (Sutent), Gastrointestinal stromal tumour, 2nd line, advanced: “Sutent is indicated for the treatment of unresectable and/or metastatic malignant gastrointestinal stromal tumour (GIST) in adults after failure of imatinib treatment due to resistance or intolerance.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/sutent-epar-product-information_en.pdf)
- **Sunitinib** (Sutent), Renal cell carcinoma, advanced: “Sutent is indicated for the treatment of advanced/metastatic renal cell carcinoma (MRCC) in adults.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/sutent-epar-product-information_en.pdf)
- **Sunitinib** (Sutent), Neuroendocrine tumours, advanced: “Sutent is indicated for the treatment of unresectable or metastatic, well-differentiated pancreatic neuroendocrine tumours (pNET) with disease progression in adults.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/sutent-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/sunitinib