Afinitor

everolimus

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 (5 and 10 mg).

What is Afinitor used for?

Afinitor is used to treat the following cancers:

• advanced 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;
• 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.

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 attaches to a protein 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?

Afinitor was compared with placebo (a dummy treatment) in two main studies. The first involved 410 patients with advanced well- or moderately differentiated neuroendocrine tumours of pancreatic origin. The second involved 416 patients with advanced renal cell carcinoma that had got worse despite treatment with a ‘VEGF-targeted’ medicine (sunitinib, sorafenib or both).

All of the patients also received best supportive care (any medicines or techniques to help patients, but not other anticancer medicines). The main measure of effectiveness 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 with advanced pancreatic neuroendocrine tumours and advanced renal cell carcinoma.

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% of patients or more) 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 and advanced renal cell carcinoma. 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.

This EPAR was last updated on 02/04/2012 .

More detail is available in the summary of product characteristics

Product details

Publication details

Product information

19/03/2012  Afinitor -EMEA/H/C/001038 -II/0015

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.

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

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.

Changes since initial authorisation of medicine

Initial marketing-authorisation documents