European Medicines Agency

Doc. Ref.: EMA/55490/2010 EMEA/H/C/540



EPAR summary for the public

This document is a summary of the European Public Assessment Report (EPAR). It explains how the Committee for Medicinal products for Human Use (CHMP) assessed the studies performed, to reach its recommendations on how to use the medicine.

If you need more information about your medical condition or your treatment, read the Package Leaflet (also part of the EPAR) or contact your doctor or pharmacist. If you want more information on the basis for the CHMP recommendations, read the Scientific Discussion (also part of the EPAR)._

What is Faslodex?

Faslodex is a solution for injection that contains the active substance fulvestrant. It is available in prefilled syringes (250 mg).

What is Faslodex used for?

Faslodex is used to treat locally advanced or metastatic breast cancer in women who have been through the menopause. It is used for cancer that is ‘oestrogen-receptor positive’ (when the cancer cells have receptors for the hormone oestrogen on their surface). ‘Locally advanced’ means that the cancer has started to spread, and ‘metastatic’ means that the cancer has already spread to other parts of the body. Faslodex is used when the disease has returned during or after treatment with an ‘anti-oestrogen’ (a type of medicine used to treat breast cancer), or when the disease has got worse during treatment with an anti-oestrogen.

The medicine can only be obtained with a prescription.

How is Faslodex used?

The recommended dose of Faslodex is 500 mg given once a month, with an additional 500-mg dose given two weeks after the first dose. Each dose is given as two slow 250-mg injections lasting one to two minutes, with one injection being given into the muscle of each buttock.

How does Faslodex work?

Most types of breast cancer grow in response to the hormone oestrogen. The active substance in Faslodex, fulvestrant, is an anti-oestrogen. It attaches to the receptors for oestrogen on the surface of cells, where it blocks the effects of the hormone and causes the number of oestrogen receptors to fall. As a result, the tumour cells are not stimulated to grow by oestrogen and the growth of the tumour is reduced.

Faslodex is absorbed slowly into the body, with the effects of each dose lasting over a month. The levels of the medicine in the body reach a steady level within a month of starting treatment.

How has Faslodex been studied?

Faslodex has been studied in three main studies involving women who had been through the menopause with advanced breast cancer that had come back or got worse after previous hormonal treatment. Two of the studies compared Faslodex taken at a dose of 250 mg once a month with

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anastrozole (another anticancer medicine) taken at a dose of 1 mg every day in 851 women. The third study compared two doses of Faslodex (250 and 500 mg) in 736 women. In all of the studies, the main measure of effectiveness was how long the patients lived without their disease getting worse.

What benefit has Faslodex shown during the studies?

In the first two studies, Faslodex was as effective as anastrozole: the women receiving Faslodex lived for an average of 5.4 months without their disease getting worse, compared with 4.1 months in those taking anastrozole. In the third study, the 500-mg dose of Faslodex was more effective than the 250-mg dose: the women receiving the higher dose lived for an average of 6.5 months without their disease getting worse, compared with 5.5 months in those receiving the lower dose.

What is the risk associated with Faslodex?

The most common side effects with Faslodex (seen in more than 1 patient in 10) are nausea (feeling sick), asthenia (weakness), injection-site reactions (such as pain or inflammation) and increased liver enzyme levels in the blood. For the full list of all side effects reported with Faslodex, see the Package Leaflet.

Faslodex should not be used in people who may be hypersensitive (allergic) to fulvestrant or any of the other ingredients. Faslodex must not be used in women who are pregnant or breast-feeding, or in patients who have severe liver disease.

Why has Faslodex been approved?

The Committee for Medicinal Products for Human Use (CHMP) decided that Faslodex’s benefits are greater than its risks and recommended that it be given marketing authorisation.

Other information about Faslodex:

The European Commission granted a marketing authorisation valid throughout the European Union for Faslodex to AstraZeneca UK Limited on 10 March 2004. The marketing authorisation is valid for an unlimited period.

The full EPAR for Faslodex can be found here.

This summary was last updated in 03-2010.