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Degarelix (FIRMAGON(R)) vs Leuprolide (Lupron Depot(R)) in Patients With Advanced Prostate Cancer: Further Analysis From a Phase III Pivotal Trial
Date:12/4/2009

"time to event" was defined as the number of days from first dosing to the first occurrence of PSA recurrence or death. PSA recurrences were analyzed by baseline PSA level.

PSA recurrence was 12.9% for leuprolide 7.5 mg/month patients compared to 7.7% with the approved degarelix 240/80 regimen. The probability of completing the study without experiencing PSA recurrence by day 364 was 91.1% (95% CI: 85.9-94.5) for degarelix and 85.9% (95% CI: 79.9-90.2) for leuprolide 7.5 mg/mo. The probability of completing the study without dying by day 364 was 97.4% (95% CI: 93.8-98.9) for degarelix versus 95.1% (95% CI: 90.7-97.4) for leuprolide 7.5 mg/mo. In patients with baseline PSA >20 ng/mL, risk of PSA recurrence was lower for patients receiving degarelix compared with leuprolide (p=0.04). The risk of PSA recurrence was comparable in patients with baseline PSA >50 ng/mL (p=0.10).

At Day 3 of treatment, the degarelix group achieved a 90 percent decrease in median testosterone levels compared with the leuprolide group, which experienced a 65 percent increase in median testosterone levels. Degarelix was as effective as leuprolide in suppressing testosterone levels from Day 28 to the end of the study (Day 364), with 97.2% of the degarelix patients maintaining medical castrate levels compared with 96.4% for leuprolide.

About FIRMAGON

FIRMAGON is an injectable gonadotropin-releasing hormone (GnRH) receptor antagonist approved by the U.S. Food and Drug Administration (FDA) for the treatment of advanced prostate cancer. As a receptor antagonist, FIRMAGON reversibly binds to the GnRH receptors in the pituitary gland, immediately suppressing the secretion of the luteinizing hormone (LH), follicle-stimulating hormone (FSH), and subsequently, testosterone levels.(1-4)

FIRMAGON also reduces levels of prostate-specific antigen (PSA). Unlike luteinizing hormone-releasing hormone (LHRH) agonists, such as leup
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SOURCE Ferring Pharmaceuticals Inc.
Copyright©2009 PR Newswire.
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