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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

PARSIPPANY, N.J., Sept. 1, 2011 /PRNewswire/ -- New data, published today in the Journal of Urology, demonstrated the long-term safety and tolerability of FIRMAGON® (degarelix) a gonadotropin-releasing hormone therapy (GnRH) for advanced prostate cancer when used over three years.(1) The new study (CS21A) was an open-label extension of the pivotal Phase III study (CS21) in which FIRMAGON® was shown to be non-inferior to leuprolide in reducing testosterone to castrate levels through one year of treatment.(1) In a retrospective analysis of CS21, risk of PSA failure was significantly lower in patients receiving degarelix versus leuprolide up to 1 year.(2) The extension study showed in an exploratory analysis that for patients who remained on FIRMAGON®, PSA suppression and the risk of PSA failure remained consistent over the long term (42 months).(1)

In addition, the extension study evaluated patients who crossed over from leuprolide to FIRMAGON® after one year in an exploratory analysis. At a median follow up of 27.5 months the data showed that the risk of PSA failure had decreased.(1)

Longer time to PSA failure is thought to be desirable as it may be indicative of time to castrationresistant prostate cancer (CRPC) and may delay initiation of second-line therapy, which includes chemotherapy.(3) Time to castration resistance is also an important predictor of CRPC survival.(4)

"This extension study supports using FIRMAGON® as first line-line androgen deprivation therapy(1) in patients with advanced prostate cancer locally advanced prostate cancer," said E. David Crawford, MD, Head, Section of Urologic Oncology and Professor of Urologic and Radiation Oncology, University of Colorado Denver, US. "The data from the Phase III open-label extension study showed that FIRMAGON® provided advanced prostate cancer patie
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SOURCE Ferring Pharmaceuticals
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