Everolimus
Also known as: Afinitor · Votubia · Afinitor Disperz · TORPENZ · Yulithira
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In short
In the European Union, everolimus is indicated under the product name Afinitor to treat hormone-receptor-positive, HER2/neu-negative advanced breast cancer in post-menopausal women without symptomatic visceral disease after recurrence or progression following a non-steroidal aromatase inhibitor. Under the same product name in the European Union, it is also indicated for progressive, unresectable or metastatic neuroendocrine tumours of pancreatic origin, progressive non-functional neuroendocrine tumours of gastrointestinal or lung origin, and advanced renal-cell carcinoma that has progressed on or after VEGF-targeted therapy. Under the product name Votubia in the European Union, everolimus is indicated for patients with tuberous sclerosis complex (TSC) who have renal angiomyolipoma at risk of complications but not requiring immediate surgery, or who have subependymal giant cell astrocytoma (SEGA) requiring intervention but not amenable to surgery. In the United States, everolimus is indicated for the treatment of adults with advanced renal cell carcinoma after failure of treatment with sunitinib or sorafenib, and for adults with renal angiomyolipoma and tuberous sclerosis complex who do not require immediate surgery. Additionally, everolimus is listed by the cited source as having an approved use for malignant neoplasm of the pancreas.
From: Source: European Medicines Agency (EMA), Afinitor — EPAR, 20/11/2025. © European Medicines Agency. · Source: European Medicines Agency (EMA), Votubia — EPAR, 20/11/2025. © European Medicines Agency. · Data provided by the U.S. Food and Drug Administration. · Source: European Medicines Agency (EMA) — EPAR. © European Medicines Agency.
AI-generated summary of the sources cited on this page, checked automatically against them. Not reviewed by a clinician; not medical advice.
Codes
- RxNorm
- 141704 everolimus
- EMA
- EMEA/H/C/001038, EMEA/H/C/002311
Official indications
Quoted unchanged from official product information, in English. Listed alphabetically by product, not ranked.
EMA (EU) Afinitor
Hormone-receptor-positive advanced breast cancer Afinitor is indicated for the treatment of hormone-receptor-positive, HER2/neu-negative advanced breast cancer, in combination with exemestane, in post-menopausal women without symptomatic visceral disease after recurrence or progression following a non-steroidal aromatase inhibitor. Neuroendocrine tumours of pancreatic origin Afinitor is indicated for the treatment of unresectable or metastatic, well or moderately differentiated neuroendocrine tumours of pancreatic origin in adults with progressive disease. Neuroendocrine tumours of gastrointestinal or lung origin Afinitor is indicated for the treatment of unresectable or metastatic, well-differentiated (Grade 1 or Grade 2) non-functional neuroendocrine tumours of gastrointestinal or lung origin in adults with progressive disease. Renal-cell carcinoma Afinitor is indicated for the treatment of patients with advanced renal-cell carcinoma, whose disease has progressed on or after treatment with VEGF-targeted therapy.
Source: European Medicines Agency (EMA), Afinitor — EPAR, 20/11/2025. © European Medicines Agency.
Document date: 20/11/2025 · Official document →
FDA (USA) Everolimus
1 INDICATIONS AND USAGE Everolimus is a kinase inhibitor indicated for the treatment of: • Adults with advanced renal cell carcinoma (RCC) after failure of treatment with sunitinib or sorafenib. ( 1.3 ) • Adults with renal angiomyolipoma and tuberous sclerosis complex (TSC), not requiring immediate surgery. ( 1.4 ) 1.3 Renal Cell Carcinoma (RCC) Everolimus is indicated for the treatment of adult patients with advanced RCC after failure of treatment with sunitinib or sorafenib. 1.4 Tuberous Sclerosis Complex (TSC)-Associated Renal Angiomyolipoma Everolimus is indicated for the treatment of adult patients with renal angiomyolipoma and TSC, not requiring immediate surgery.
Data provided by the U.S. Food and Drug Administration.
Document date: 20260814 · Official document →
EMA (EU) Votubia
Renal angiomyolipoma associated with tuberous sclerosis complex (TSC) Votubia is indicated for the treatment of adult patients with renal angiomyolipoma associated with tuberous sclerosis complex (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. The evidence is based on analysis of change in sum of angiomyolipoma volume. Subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis complex (TSC) Votubia is indicated for the treatment of patients with subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis complex (TSC) who require therapeutic intervention but are not amenable to surgery. The evidence is based on analysis of change in SEGA volume. Further clinical benefit, such as improvement in disease?related symptoms, has not been demonstrated.
Source: European Medicines Agency (EMA), Votubia — EPAR, 20/11/2025. © European Medicines Agency.
Document date: 20/11/2025 · Official document →
Related terms in the cited sources
Has an official indication for
- Pancreatic cancer Condition
In alphabetical order.
Other treatments A–Z
What people report
Not enough data yet. Anonymous counts appear here only for groups of at least 20 people who agreed to share them.
External resources
Questions
What is Everolimus approved for in the European Union?
Hormone-receptor-positive advanced breast cancer Afinitor is indicated for the treatment of hormone-receptor-positive, HER2/neu-negative advanced breast cancer, in combination with exemestane, in post-menopausal women without symptomatic visceral disease after recurrence or progression following a non-steroidal aromatase inhibitor. Neuroendocrine tumours of pancreatic origin Afinitor is indicated for the treatment of unresectable or metastatic, well or moderately differentiated neuroendocrine tumours of pancreatic origin in adults with progressive disease. Neuroendocrine tumours of gastrointestinal or lung origin Afinitor is indicated for the treatment of unresectable or metastatic, well-differentiated (Grade 1 or Grade 2) non-functional neuroendocrine tumours of gastrointestinal or lung origin in adults with progressive disease. Renal-cell carcinoma Afinitor is indicated for the treatment of patients with advanced renal-cell carcinoma, whose disease has progressed on or after treatment with VEGF-targeted therapy. (Source: European Medicines Agency (EMA), Afinitor — EPAR, 20/11/2025. © European Medicines Agency.)
Sources and attribution
- Source: European Medicines Agency (EMA) — EPAR. © European Medicines Agency.
- Data provided by the U.S. Food and Drug Administration.
- Names other than the official source titles: Anpheros translations and plain-language names, made with AI assistance and checked automatically; the source names are in English.
- This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product.
- Source: European Medicines Agency (EMA), Afinitor — EPAR, 20/11/2025. © European Medicines Agency.
- Source: European Medicines Agency (EMA), Votubia — EPAR, 20/11/2025. © European Medicines Agency.
Anpheros Search catalog 2026.10.5, published 17 October 2026. About the data →
About this page. This page brings together public information from official sources, each cited where it is used. It is not medical advice, it is not a diagnosis, and it does not tell you which treatment to take.
Treatments. Indications are quoted unchanged from official product information (European Medicines Agency, U.S. Food and Drug Administration). They describe what a medicine is approved for, not whether it is right for you. Approved uses can differ between countries. Always read the package leaflet and follow your doctor's or pharmacist's advice.
What people report. Figures marked "reported by Anpheros users" are anonymous counts from at least 20 people who agreed to share them. They show what people report, not what works, and they are not clinical evidence.
Links between terms. "May be associated with" means the link appears in a cited source. It does not mean you have that condition.
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