# Vandetanib

Vandetanib (Caprelsa, Esteve Pharmaceuticals, S.A.) has 1 EU-approved indication in 1 tumour type. It needs a biomarker result: RET (1).

## Approved indications

### Thyroid cancer

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| RET mutation | Monotherapy | Advanced | Medullary thyroid cancer only; Aggressive and symptomatic disease; aged 5 years and older |

## Products

### Caprelsa

- Company: Esteve Pharmaceuticals, S.A.
- Target: Multikinase inhibitor (VEGFR, EGFR, RET)
- Class: Other protein kinase inhibitors
- ATC: L01EX04
- EU approval: 16 Feb 2012
- Label revised: 5 Aug 2026
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/caprelsa-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/caprelsa-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/caprelsa

Mechanism (SmPC section 5.1): Inhibits VEGFR-2, EGFR, and RET tyrosine kinases, thereby reducing angiogenesis, vascular permeability, and tumor cell proliferation and survival.

## Label wording

- **Vandetanib** (Caprelsa), Thyroid cancer, advanced: “Caprelsa is indicated for the treatment of aggressive and symptomatic Rearranged during Transfection (RET) mutant medullary thyroid cancer (MTC) in patients with unresectable locally advanced or metastatic disease.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/caprelsa-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/vandetanib