Afinitor

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everolimus

Authorised
This medicine is authorised for use in the European Union.

Overview

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.

This EPAR was last updated on 11/12/2018

Authorisation details

Product details
Name
Afinitor
Agency product number
EMEA/H/C/001038
Active substance
everolimus
International non-proprietary name (INN) or common name
everolimus
Therapeutic area (MeSH)
  • Carcinoma, Renal Cell
  • Breast Neoplasms
  • Pancreatic Neoplasms
Anatomical therapeutic chemical (ATC) code
L01XE10
Publication details
Marketing-authorisation holder
Novartis Europharm Limited
Revision
22
Date of issue of marketing authorisation valid throughout the European Union
02/08/2009
Contact address

Elm Park, Merrion Road
Dublin 4
Ireland

Product information

20/09/2018 Afinitor - EMEA/H/C/001038 - II/0058

Contents

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Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

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.

Assessment history

Changes since initial authorisation of medicine

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