Afinitor

everolimus

  • Email
  • Help

About

This is a summary of the European public assessment report (EPAR) for Afinitor. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Afinitor.

What is Afinitor?

Afinitor is a medicine that contains the active substance everolimus. It is available as tablets (2.5, 5 and 10 mg).

What is Afinitor used for?

Afinitor is used to treat the following cancers:

  • breast cancer that is advanced (has started to spread) and hormone-receptor-positive (when the cancer cells have receptors for hormones on their surface) in women who have been through their menopause. It is used together with a medicine called exemestane after other treatments called ‘non-steroidal aromatase inhibitors’ have failed;
  • 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 have a similar appearance to normal pancreas cells) and the cancer is getting worse. It is used when the cancer is metastatic (has spread to other parts of the body) or when it cannot be surgically removed;
  • advanced renal-cell carcinoma (a type of kidney cancer), when the cancer has worsened despite treatment with a type of medicine called a ‘VEGF-targeted’ medicine.

The medicine can only be obtained with a prescription.

How is Afinitor used?

Treatment with Afinitor should be started and supervised by a doctor who has experience in the use of anticancer treatments.

The recommended dose of Afinitor is 10 mg once a day. Treatment should continue for as long as the patient benefits from it or until the patient develops unacceptable side effects. The doctor may reduce the dose or stop treatment for a short period if the patient has severe or intolerable side effects. Doses need to be reduced for patients with liver problems.

The tablets should be swallowed whole at the same time every day and should not be chewed or crushed. They should be taken consistently with or without food.

How does Afinitor work?

The active substance in Afinitor, everolimus, is an anticancer medicine, which acts by blocking a protein called ‘mammalian target of rapamycin’ (mTOR). In the body, everolimus first attaches to a protein called FKBP-12 that is found inside cells to make a ‘complex’. This complex then blocks mTOR. Since mTOR is involved in the control of cell division and the growth of blood vessels, Afinitor prevents the division of tumour cells and reduces their blood supply. This slows down the growth and spread of the tumours.

How has Afinitor been studied?

The effects of Afinitor were studied in three main studies. The first study involved 724 patients with hormone-receptor-positive advanced breast cancer which had got worse after treatment with letrozole and anastrazole (‘non-steroidal-aromatase-inhibitor’ anticancer medicines). In addition, all patients in this study received exemestane. The second study involved 410 patients with advanced well or moderately differentiated neuroendocrine tumours of pancreatic origin. The third study involved 416 patients with advanced renal-cell carcinoma that had got worse despite treatment with a VEGF-targeted medicine (sunitinib, sorafenib or both).

The main measure of effectiveness in the three studies was how long the patients lived without the disease getting worse

What benefit has Afinitor shown during the studies?

Afinitor was more effective than placebo at treating patients in all studies.

In the breast-cancer study, patients who took Afinitor lived for an average of 7.8 months without their disease getting worse, compared with 3.2 months for the patients who took placebo.

In the pancreatic-neuroendocrine study, patients who took Afinitor lived for an average of 11 months without the disease getting worse, compared with 4.6 months for the patients who took placebo.

In the renal-cell-carcinoma study, patients who took Afinitor lived for an average of 4.9 months without the disease getting worse, compared with 1.9 months for the patients who took placebo.

What is the risk associated with Afinitor?

The most common severe side effects with Afinitor (seen in 2 or more patients in 100) are anaemia (low red-blood-cell counts), fatigue (tiredness), diarrhoea, infections, stomatitis (inflammation of the lining of the mouth), hyperglycaemia (high blood glucose levels), low levels of platelets, low levels of lymphocytes and neutrophils (types of white blood cell), hypophosphataemia (low blood levels of phosphates), hypercholesterolaemia (high blood cholesterol levels), diabetes mellitus and pneumonitis (inflammation of the lungs). For the full list of all side effects reported with Afinitor, see the package leaflet.

Afinitor must not be used in people who are hypersensitive (allergic) to everolimus, to other rapamycin derivatives (substances with a similar structure to everolimus) or to any of the other ingredients.

Why has Afinitor been approved?

The CHMP decided that Afinitor was shown to slow down disease progression in patients with advanced neuroendocrine tumours of pancreatic origin, advanced renal-cell carcinoma and hormone-receptor-positive advanced breast cancer. The CHMP concluded that the benefits of Afinitor are greater than its risks and recommended that it be granted marketing authorisation.

Other information about Afinitor

The European Commission granted a marketing authorisation valid throughout the European Union for Afinitor on 3 August 2009.

For more information about treatment with Afinitor, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Name Language First published Last updated
Afinitor : EPAR - Summary for the public BG = bălgarski 15/04/2010 25/01/2013
Afinitor : EPAR - Summary for the public ES = español 15/04/2010 25/01/2013
Afinitor : EPAR - Summary for the public CS = čeština 15/04/2010 25/01/2013
Afinitor : EPAR - Summary for the public DA = dansk 15/04/2010 25/01/2013
Afinitor : EPAR - Summary for the public DE = Deutsch 15/04/2010 25/01/2013
Afinitor : EPAR - Summary for the public ET = eesti keel 15/04/2010 25/01/2013
Afinitor : EPAR - Summary for the public EL = elliniká 15/04/2010 25/01/2013
Afinitor : EPAR - Summary for the public EN = English 15/04/2010 25/01/2013
Afinitor : EPAR - Summary for the public FR = français 15/04/2010 25/01/2013
Afinitor : EPAR - Summary for the public IT = italiano 15/04/2010 25/01/2013
Afinitor : EPAR - Summary for the public LV = latviešu valoda 15/04/2010 25/01/2013
Afinitor : EPAR - Summary for the public LT = lietuvių kalba 15/04/2010 25/01/2013
Afinitor : EPAR - Summary for the public HU = magyar 15/04/2010 25/01/2013
Afinitor : EPAR - Summary for the public MT = Malti 15/04/2010 25/01/2013
Afinitor : EPAR - Summary for the public NL = Nederlands 15/04/2010 25/01/2013
Afinitor : EPAR - Summary for the public PL = polski 15/04/2010 25/01/2013
Afinitor : EPAR - Summary for the public PT = português 15/04/2010 25/01/2013
Afinitor : EPAR - Summary for the public RO = română 15/04/2010 25/01/2013
Afinitor : EPAR - Summary for the public SK = slovenčina 15/04/2010 25/01/2013
Afinitor : EPAR - Summary for the public SL = slovenščina 15/04/2010 25/01/2013
Afinitor : EPAR - Summary for the public FI = suomi 15/04/2010 25/01/2013
Afinitor : EPAR - Summary for the public SV = svenska 15/04/2010 25/01/2013

This EPAR was last updated on 12/06/2014 .

Authorisation details

Product details

Product details for Afinitor
NameAfinitor
Agency product numberEMEA/H/C/001038
Active substance

everolimus

International non-proprietary name (INN) or common name

everolimus

Therapeutic area Carcinoma, Renal CellPancreatic NeoplasmsBreast Neoplasms
Anatomical therapeutic chemical (ATC) code L01XE10

Publication details

Publication details for Afinitor
Marketing-authorisation holder

Novartis Europharm Ltd.

Revision12
Date of issue of marketing authorisation valid throughout the European Union03/08/2009

Contact address:

Novartis Europharm Limited
Wimblehurst Road
Horsham
West Sussex
RH12 5AB
United Kingdom

Product information

Product information

16/05/2014  Afinitor -EMEA/H/C/001038 -R/0036

Name Language First published Last updated
Afinitor : EPAR - Product Information SV = svenska 02/09/2009 12/06/2014
Afinitor : EPAR - Product Information SV = svenska 02/09/2009 12/06/2014
Afinitor : EPAR - Product Information SV = svenska 02/09/2009 12/06/2014
Afinitor : EPAR - Product Information SV = svenska 02/09/2009 12/06/2014
Afinitor : EPAR - Product Information SV = svenska 02/09/2009 12/06/2014
Afinitor : EPAR - Product Information SV = svenska 02/09/2009 12/06/2014
Afinitor : EPAR - Product Information SV = svenska 02/09/2009 12/06/2014
Afinitor : EPAR - Product Information SV = svenska 02/09/2009 12/06/2014
Afinitor : EPAR - Product Information SV = svenska 02/09/2009 12/06/2014
Afinitor : EPAR - Product Information SV = svenska 02/09/2009 12/06/2014
Afinitor : EPAR - Product Information SV = svenska 02/09/2009 12/06/2014
Afinitor : EPAR - Product Information SV = svenska 02/09/2009 12/06/2014
Afinitor : EPAR - Product Information SV = svenska 02/09/2009 12/06/2014
Afinitor : EPAR - Product Information SV = svenska 02/09/2009 12/06/2014
Afinitor : EPAR - Product Information SV = svenska 02/09/2009 12/06/2014
Afinitor : EPAR - Product Information SV = svenska 02/09/2009 12/06/2014
Afinitor : EPAR - Product Information SV = svenska 02/09/2009 12/06/2014
Afinitor : EPAR - Product Information SV = svenska 02/09/2009 12/06/2014
Afinitor : EPAR - Product Information SV = svenska 02/09/2009 12/06/2014
Afinitor : EPAR - Product Information SV = svenska 02/09/2009 12/06/2014
Afinitor : EPAR - Product Information SV = svenska 02/09/2009 12/06/2014
Afinitor : EPAR - Product Information SV = svenska 02/09/2009 12/06/2014
Afinitor : EPAR - Product Information SV = svenska 02/09/2009 12/06/2014
Afinitor : EPAR - Product Information SV = svenska 02/09/2009 12/06/2014
Afinitor : EPAR - Product Information SV = svenska 02/09/2009 12/06/2014

Contents

  • 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.


Name Language First published Last updated
Afinitor : EPAR - All Authorised presentations SV = svenska 02/09/2009 12/06/2014
Afinitor : EPAR - All Authorised presentations SV = svenska 02/09/2009 12/06/2014
Afinitor : EPAR - All Authorised presentations SV = svenska 02/09/2009 12/06/2014
Afinitor : EPAR - All Authorised presentations SV = svenska 02/09/2009 12/06/2014
Afinitor : EPAR - All Authorised presentations SV = svenska 02/09/2009 12/06/2014
Afinitor : EPAR - All Authorised presentations SV = svenska 02/09/2009 12/06/2014
Afinitor : EPAR - All Authorised presentations SV = svenska 02/09/2009 12/06/2014
Afinitor : EPAR - All Authorised presentations SV = svenska 02/09/2009 12/06/2014
Afinitor : EPAR - All Authorised presentations SV = svenska 02/09/2009 12/06/2014
Afinitor : EPAR - All Authorised presentations SV = svenska 02/09/2009 12/06/2014
Afinitor : EPAR - All Authorised presentations SV = svenska 02/09/2009 12/06/2014
Afinitor : EPAR - All Authorised presentations SV = svenska 02/09/2009 12/06/2014
Afinitor : EPAR - All Authorised presentations SV = svenska 02/09/2009 12/06/2014
Afinitor : EPAR - All Authorised presentations SV = svenska 02/09/2009 12/06/2014
Afinitor : EPAR - All Authorised presentations SV = svenska 02/09/2009 12/06/2014
Afinitor : EPAR - All Authorised presentations SV = svenska 02/09/2009 12/06/2014
Afinitor : EPAR - All Authorised presentations SV = svenska 02/09/2009 12/06/2014
Afinitor : EPAR - All Authorised presentations SV = svenska 02/09/2009 12/06/2014
Afinitor : EPAR - All Authorised presentations SV = svenska 02/09/2009 12/06/2014
Afinitor : EPAR - All Authorised presentations SV = svenska 02/09/2009 12/06/2014
Afinitor : EPAR - All Authorised presentations SV = svenska 02/09/2009 12/06/2014
Afinitor : EPAR - All Authorised presentations SV = svenska 02/09/2009 12/06/2014
Afinitor : EPAR - All Authorised presentations SV = svenska 02/09/2009 12/06/2014
Afinitor : EPAR - All Authorised presentations SV = svenska 02/09/2009 12/06/2014
Afinitor : EPAR - All Authorised presentations SV = svenska 02/09/2009 12/06/2014

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.

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

Initial marketing-authorisation documents

Name Language First published Last updated
Afinitor : EPAR - Public assessment report SV = svenska 02/09/2009  
Committee for medicinal products for human use summary of positive opinion for Afinitor SV = svenska 29/05/2009  

Authorised

This medicine is approved for use in the European Union

More information on Afinitor

This product is no longer an orphan medicine. It was originally designated an orphan medicine on 5 June 2007. Upon request of the marketing-authorisation holder, Afinitor has now been removed from the Community register of orphan medicinal products.