# Everolimus

Everolimus (Afinitor, Votubia, Novartis Europharm Limited) has 6 EU-approved indications in 5 tumour types. 1 needs a biomarker result: Hormone receptor (1).

## Approved indications

### Breast cancer

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| Hormone receptor-positive, HER2-negative | + exemestane | 2nd line, advanced | Recurrence or progression following a non-steroidal aromatase inhibitor; Postmenopausal women; without symptomatic visceral disease |

### Neuroendocrine tumours

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| None | Monotherapy | Advanced | Pancreatic NET only; Well- or moderately-differentiated; progressive disease |
| None | Monotherapy | Advanced | Gastrointestinal or lung NET only; Well-differentiated (Grade 1 or Grade 2); non-functional; progressive disease Ambiguous in the label (tumour site): check the SmPC. |

### Renal angiomyolipoma

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| 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 |

### Renal cell carcinoma

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| None | Monotherapy | 2nd line, advanced | Progressed on or after treatment with VEGF-targeted therapy |

### Glioma

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| None | Monotherapy | Any line | SEGA with tuberous sclerosis only; Tuberous sclerosis complex; require therapeutic intervention but are not amenable to surgery |

## Products

### Afinitor

- Company: Novartis Europharm Limited
- Target: mTOR inhibitor
- Class: Mammalian target of rapamycin (mTOR) kinase inhibitors
- ATC: L01EG02
- EU approval: 2 Aug 2009
- Label revised: 20 Nov 2025
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/afinitor-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/afinitor-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/afinitor

Mechanism (SmPC section 5.1): Binds to intracellular FKBP-12 to form a complex that inhibits mTORC1 activity, reducing protein synthesis, cell cycle progression, and angiogenesis.

### Votubia

- Company: Novartis Europharm Limited
- Target: mTOR inhibitor
- Class: Mammalian target of rapamycin (mTOR) kinase inhibitors
- ATC: L01EG02
- EU approval: 2 Sep 2011
- Label revised: 20 Nov 2025
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/votubia-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/votubia-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/votubia

Mechanism (SmPC section 5.1): Everolimus binds intracellular FKBP-12 to inhibit mTORC1 activity, blocking downstream signalling that regulates protein synthesis, the cell cycle, angiogenesis, and glycolysis.

## Label wording

- **Everolimus** (Afinitor), Breast cancer, 2nd line, advanced: “Afinitor is indicated for the treatment of hormone receptor-positive, HER2/neu negative advanced breast cancer, in combination with exemestane, in postmenopausal women without symptomatic visceral disease after recurrence or progression following a non-steroidal aromatase inhibitor.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/afinitor-epar-product-information_en.pdf)
- **Everolimus** (Afinitor), Neuroendocrine tumours, advanced: “Afinitor is indicated for the treatment of unresectable or metastatic, well- or moderately-differentiated neuroendocrine tumours of pancreatic origin in adults with progressive disease.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/afinitor-epar-product-information_en.pdf)
- **Everolimus** (Afinitor), Neuroendocrine tumours, advanced: “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 (see sections 4.4 and 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/afinitor-epar-product-information_en.pdf)
- **Everolimus** (Afinitor), Renal cell carcinoma, 2nd line, advanced: “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.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/afinitor-epar-product-information_en.pdf)
- **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)
- **Everolimus** (Votubia), Glioma, any line: “Votubia is indicated for the treatment of adult and paediatric patients with SEGA associated with TSC who require therapeutic intervention but are not amenable to 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/drugs/everolimus