EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) FIRMAGON

EPAR summary for the public

What is Firmagon?

Firmagon is a powder and solvent that are made up into a solution for injection. It contains the active substance degarelix.

What is Firmagon used for?

Firmagon is used to treat patients with advanced prostate cancer. This is cancer that affects the prostate gland, the gland below the bladder in men that produces the liquid in the semen. ‘Advanced’ means that the cancer has spread beyond the gland to some lymph nodes, but not to other organs. Firmagon can be used if the cancer is ‘hormone-dependent’, which means that it responds to treatments that reduce the levels of the hormone testosterone.

The medicine can only be obtained with a prescription.

How is Firmagon used?

Firmagon is injected under the skin of the abdomen. Treatment starts with two 120-mg injections, followed by single 80-mg injections every month. Firmagon must not be injected into a vein or a muscle. Doctors should monitor the effectiveness of Firmagon treatment by looking at blood levels of testosterone and prostate-specific antigen (PSA). PSA is a protein that is produced by the prostate gland and is often found at high levels in men with prostate cancer.

Firmagon should be used with caution in patients who have severe kidney or liver problems.

How does Firmagon work?

Testosterone can make prostate cancer cells grow. The active substance in Firmagon, degarelix, is a gonadotrophin-releasing hormone antagonist, which means that it blocks the effects of a natural hormone called gonadotrophin-releasing hormone (GnRH). GnRH normally stimulates the pituitary gland at the base of the brain to produce two hormones which cause the testes to produce testosterone. By blocking these processes, Firmagon reduces the amount of testosterone in the body and slows down the growth of the cancer cells. When injected, Firmagon forms a gel under the skin that releases the active substance slowly over a few weeks.

How has Firmagon been studied?

The effects of Firmagon were first tested in experimental models before being studied in humans.

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Two doses of Firmagon have been compared with leuprorelin in one main study involving 610 men with prostate cancer at all stages of the disease. The main measure of effectiveness was the number of patients whose testosterone levels were below those seen in men whose testes were producing no testosterone, over the first year of treatment.

What benefit has Firmagon shown during the studies?

Firmagon was as effective as leuprorelin at reducing testosterone levels. During the first year, 97% of the patients receiving Firmagon at the approved dose of 80 mg once a month dose had testosterone levels below the required level. This was compared with 96% of patients receiving leuprorelin. Similar results were seen in patients receiving Firmagon at the higher dose of 160 mg once a month.

What is the risk associated with Firmagon?

The most common side effects with Firmagon (seen in more than 1 patient in 10) are hot flushes and problems at the injection site such as pain and redness. For the full list of all side effects reported with Firmagon, see the Package Leaflet.

Firmagon should not be used in people who may be hypersensitive (allergic) to degarelix or any of the other ingredients.

Why has Firmagon been approved?

The Committee for Medicinal Products for Human Use (CHMP) noted that Firmagon was as effective as leuprorelin in the main study. However, because the main study looked at the medicine’s effects on testosterone levels rather than the cancer or the patient’s outcome directly, and because leuprorelin is only used for prostate cancer that is advanced, the Committee decided to restrict the use of Firmagon to advanced prostate cancer.

The Committee also noted that treatment with Firmagon does not trigger the temporary sharp rise in testosterone levels seen with ‘GnRH agonists’ (other medicines for prostate cancer that stimulate the production of GnRH). This means that patients do not need to take other medicines to block testosterone at the start of treatment.

Therefore, the CHMP decided that Firmagon’s benefits are greater than its risks for the treatment of adult male patients with advanced hormone-dependent prostate cancer. The Committee recommended that Firmagon be given marketing authorisation

Which measures are being taken to ensure the safe use of Firmagon?

The company that makes Firmagon will make sure that educational materials are provided to all doctors in all Member States who will prescribe the medicine. The materials will include information on Firmagon’s safety and remind doctors how to administer the medicine.

Other information about Firmagon:

The European Commission granted a marketing authorisation valid throughout the European Union for Firmagon to Ferring Pharmaceuticals A/S on 17 February 2009.

The full EPAR for Firmagon can be found here.

This summary was last updated in 01-2009.

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