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New Data on Long-Term Use of FIRMAGON® (degarelix for injection) for Advanced Hormone-Dependant Prostate Cancer Published in Journal of Urology
Date:9/1/2011

nts with safe and effective testosterone and PSA control over the long term, reducing the risk of PSA failure."

Prostate cancer is the second leading cause of cancer death amongst men in the Western world.(5) Up to 40% of men diagnosed with prostate cancer will eventually develop advanced disease, and although most respond to initial medical or surgical castration, progression to CRPC is inevitable(6). The average survival for patients with CRPC is two to three years.(6)

FIRMAGON® works by immediately inhibiting the GnRH receptors in the pituitary gland and suppressing the luteinising hormone, which decreases production of testosterone by the testicles with no initial surge. Prostate cancer is dependent on testosterone for its growth, so the goal of therapy is to rapidly reduce testosterone levels to slow the growth of cancer cells.

Notes to Editors

About Study CS21

In the Phase III multicenter, randomized, open-label trial comparing FIRMAGON with leuprolide, prostate cancer patients (n=610) were randomized to a FIRMAGON starting dose of 240 mg for one month, followed by monthly maintenance doses of 80 mg (n=207) or 160 mg (n=202), or leuprolide 7.5 mg/month (n=201). The trial was powered to demonstrate non-inferiority of degarelix versus leuprolide for the primary end point (proportion of patients with testosterone suppression < 50 ng/dL during 12 months' treatment). Data for the 240/160 mg group have not been analyzed beyond 1 year; after 1 year patients randomized to the 160 mg dose were switched to the approved 80 mg dose following regulatory approval of this dose. Patients crossed over from the leuprolide group were given FIRMAGON starting dose 240 mg followed by monthly maintenance dose of 80 mg.

About Prostate Cancer

Prostate cancer is the most common form of male cancer in the western world,(2) and the second leading cause of cancer death in men in some cou
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SOURCE Ferring Pharmaceuticals
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