# Renal angiomyolipoma

The EU has approved 1 indication of 1 drug in renal angiomyolipoma. None of them needs a biomarker result.

## Approved indications

### No biomarker required

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Everolimus](https://oncolabels.com/drugs/everolimus) (Votubia) | None | Monotherapy | Any line | Tuberous sclerosis complex; at risk of complications (based on factors such as tumour size or presence of aneurysm, or presence of multiple or bilateral tumours) but who do not require immediate surgery |

## Label wording

- **Everolimus** (Votubia), Renal angiomyolipoma, any line: “Votubia is indicated for the treatment of adult patients with renal angiomyolipoma associated with TSC who are at risk of complications (based on factors such as tumour size or presence of aneurysm, or presence of multiple or bilateral tumours) but who do not require immediate surgery.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/votubia-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/tumours/renal-angiomyolipoma