Afinitor is a cancer medicine used to treat the following cancers:
- breast cancer that is advanced (has started to spread) in women who have been through their menopause. Afinitor is used in breast cancer that is ‘hormone receptor-positive’ (when the cancer cells have oestrogen receptors on their surface) and ‘HER2/neu negative’ (when the cancer cells do not contain high levels of the HER2/neu [human epidermal growth factor receptor-2] protein). Afinitor is used together with a medicine called exemestane after other treatments called ‘non-steroidal aromatase inhibitors’ have not worked;
- pancreatic neuroendocrine tumours (tumours of the hormone-producing cells in the pancreas) when the cancer cells are well- or moderately differentiated (which means that they can be distinguished from normal pancreas cells). It is used when the cancer is metastatic (has spread to other parts of the body) or when it cannot be surgically removed;
- neuroendocrine tumours originating in the lungs or gut, when the cancer cells are well-differentiated and the cancer is metastatic or cannot be removed by surgery.
- advanced renal cell carcinoma (a kidney cancer), when the cancer has worsened despite treatment with a ‘VEGF-targeted’ medicine (a type of medicine that blocks the effects of vascular endothelial growth factor proteins).
Afinitor contains the active substance everolimus.
Afinitor : EPAR - Summary for the public (PDF/86.6 KB)
First published: 15/04/2010
Last updated: 11/12/2018
Afinitor : EPAR - Risk-management-plan summary (PDF/123.23 KB)
First published: 25/02/2020
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
Novartis Europharm Limited
|Date of issue of marketing authorisation valid throughout the European Union||
09/06/2020 Afinitor - EMEA/H/C/001038 - IB/0067/G
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
Please note that the size of the above document can exceed 50 pages.
You are therefore advised to be selective about which sections or pages you wish to print.
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.
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.