FIRMAGON® (degarelix for injection) DROPS PROSTATE-SPECIFIC ANTIGEN (PSA) LEVELS
When Testosterone drops, PSA reduction follows
FIRMAGON RESULTED IN A REDUCTION OF PROSTATE-SPECIFIC ANTIGEN (PSA) LEVELS, A SECONDARY ENDPOINT1*
REDUCTION IN PSA LEVELS FOR PATIENTS RECEIVING FIRMAGON (N=207)1
FIRMAGON maintained PSA suppression through 12 months of treatment1
START T SUPPRESSION TODAY1
Prostate-specific antigen (PSA) level is a nonspecific measurement that may indicate cancer progression. These PSA results should be interpreted with caution because of the heterogeneity of the patient population studied. No evidence has shown that the rapidity of PSA decline is related to clinical benefit. Therefore, PSA data should not be viewed independently as evidence of the effectiveness of FIRMAGON.1
The pivotal phase 3 trial (CS21) was a 3-armed, randomized (1:1:1), active-controlled, open-label, parallel-group, 12-month clinical study of FIRMAGON compared to leuprolide acetate (Lupron Depot®).2 Serum levels of testosterone were measured at screening, on days 0, 1, 3, 7, 14,and 28 in the first month, and then monthly until the end of the study.1
FIRMAGON was shown to maintain testosterone suppression below castration level (≤50 ng/dL) during 12 months of treatment.
- Proportion of patients with testosterone ≤50 ng/dL
- Serum levels of testosterone, prostate-specific antigen (PSA), luteinizing hormone (LH), and follicle-stimulating hormone (FSH) over time
- Percentage change in PSA from baseline
Abbreviations: ADT = androgen deprivation therapy; FSH = follicle-stimulating hormone; LH = luteinizing hormone; PSA = prostate-specific antigen; T = testosterone.
Lupron Depot is a registered trademark of ABBVIE ENDOCRINE INC.
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REFERENCES: 1. FIRMAGON® [package insert]. Parsippany, NJ: Ferring Pharmaceuticals Inc. 2. Klotz L, Boccon-Gibod L, Shore ND, et al. The efficacy and safety of degarelix: a 12-month, comparative, randomized, open-label, parallel-group phase III study in patients with prostate cancer. BJU Int. 2008;102(11):1531-1538.