# Axitinib

Axitinib (Inlyta, Pfizer Europe MA EEIG) has 1 EU-approved indication in 1 tumour type.

## Approved indications

### Renal cell carcinoma

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| None | Monotherapy | 2nd line, advanced | Failure of prior treatment with sunitinib or a cytokine |

## Products

### Inlyta

- Company: Pfizer Europe MA EEIG
- Target: VEGFR tyrosine kinase inhibitor
- Class: Vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitors
- ATC: L01EK01
- EU approval: 3 Sep 2012
- Label revised: 22 Jan 2025
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/inlyta-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/inlyta-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/inlyta
- Biosimilars and generics: Axitinib Accord

Mechanism (SmPC section 5.1): Axitinib selectively inhibits VEGFR-1, VEGFR-2, and VEGFR-3 tyrosine kinases, blocking VEGF-mediated endothelial cell proliferation and survival to inhibit pathologic angiogenesis and tumor growth.

## Label wording

- **Axitinib** (Inlyta), Renal cell carcinoma, 2nd line, advanced: “Inlyta is indicated for the treatment of adult patients with advanced renal cell carcinoma (RCC) after failure of prior treatment with sunitinib or a cytokine.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/inlyta-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/axitinib