Renal angiomyolipoma

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

Line of therapy

Approved indications, Renal angiomyolipoma
DrugBiomarker requirementRegimenSettingConditions
No biomarker required1
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 wording1

The sentence from section 4.1 of the SmPC that each indication above comes from.

  1. Everolimus (Votubia)
    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.