# Tivozanib

Tivozanib (Fotivda, Recordati Netherlands B.V.) has 2 EU-approved indications in 1 tumour type.

## Approved indications

### Renal cell carcinoma

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| None | Monotherapy | 1st line, advanced | - |
| None | Monotherapy | 2nd line, advanced | After one prior treatment with cytokine therapy; VEGFR and mTOR pathway inhibitor-naïve |

## Products

### Fotivda

- Company: Recordati Netherlands B.V.
- Target: VEGFR tyrosine kinase inhibitor
- Class: Vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitors
- ATC: L01EK03
- EU approval: 24 Aug 2017
- Label revised: 17 Jul 2023
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/fotivda-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/fotivda-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/fotivda

Mechanism (SmPC section 5.1): Tivozanib selectively blocks VEGFR 1, 2, and 3 phosphorylation and activation, inhibiting endothelial cell proliferation, angiogenesis, vascular permeability, and tumour growth.

## Label wording

- **Tivozanib** (Fotivda), Renal cell carcinoma, 1st line, advanced: “Fotivda is indicated for the first line treatment of adult patients with advanced renal cell carcinoma (RCC) and for adult patients who are VEGFR and mTOR pathway inhibitor-naïve following disease progression after one prior treatment with cytokine therapy for advanced RCC.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/fotivda-epar-product-information_en.pdf)
- **Tivozanib** (Fotivda), Renal cell carcinoma, 2nd line, advanced: “Fotivda is indicated for the first line treatment of adult patients with advanced renal cell carcinoma (RCC) and for adult patients who are VEGFR and mTOR pathway inhibitor-naïve following disease progression after one prior treatment with cytokine therapy for advanced RCC.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/fotivda-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/tivozanib