Authors: Natalie J Carter Susan J Keam
Publish Date: 2014/04/23
Volume: 74, Issue: 6, Pages: 699-712
Abstract
Degarelix Firmagon® Gonax® is a gonadotropinreleasing hormone receptor antagonist that is approved for the treatment of advanced hormonedependent prostate cancer in the US and EU and the treatment of prostate cancer in Japan In a pivotal randomized controlled 12month phase III study degarelix initial subcutaneous dose of 240 mg followed by monthly dosages of 80 mg was noninferior to leuprolide monthly intramuscular dosages of 75 mg in patients with prostate cancer of any stage for which endocrine treatment was indicated except neoadjuvant hormonal therapy with regard to suppression of testosterone to castration levels ie ≤05 ng/mL Suppression of testosterone and prostatespecific antigen PSA levels was faster with degarelix than with leuprolide and no testosterone surges or microsurges were seen in degarelix recipients Suppression of testosterone and PSA levels was maintained for the 12month study duration and continued for up to 5 years in an extension to the main trial including in patients switching from leuprolide to degarelix in the extension The drug was generally well tolerated with most adverse events being mild to moderate in severity Injectionsite reactions and events reflecting the expected effects of testosterone suppression eg hot flushes weight increase were the most common treatmentemergent adverse events Thus degarelix is a useful option for the treatment of prostate cancer in patients for whom endocrine treatment is indicatedThe preparation of this review was not supported by any external funding During the peer review process the manufacturer of the agent under review was offered an opportunity to comment on this article Changes resulting from comments received were made by the author on the basis of scientific and editorial merit Natalie Carter and Susan Keam are salaried employees of Adis/Springer
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