VIENNA, Austria, March 21, 2011 /PRNewswire/ -- Recent data from the ongoing five-year FIRMAGON(R) (degarelix) extension study (CS21a) has demonstrated the long term efficacy and tolerability of FIRMAGON(R) in study patients with advanced hormone-dependent prostate cancer and support its use as first-line androgen deprivation therapy.[1] Full details were shared today at the European Association of Urology (EAU) 2011 Annual Meeting.

FIRMAGON(R), a gonadotropin-releasing hormone (GnRH) receptor blocker, is indicated for the treatment of patients with advanced hormone-dependent prostate cancer. The extension study of the pivotal FIRMAGON(R) vs leuprorelin trial (CS21) was designed to collect extended safety and tolerability data on FIRMAGON(R). Following the close of the Phase III trial, all patients were offered the option to receive FIRMAGON(R) as part of the extension study. All patients who had received FIRMAGON(R) continued with their treatment and those who had previously been treated with leuprorelin (a GnRH agonist) were re-randomised to receive FIRMAGON(R) 240/80mg or 240/160mg.

To date, data from the extension study show that all patients receiving FIRMAGON(R) experienced improved PSA control, specifically:

- Beyond one year, prostate-specific antigen (PSA) suppression was maintained in patients continuing treatment on FIRMAGON(R) [1,2]

- After switching to FIRMAGON(R) patients who initially received leuprorelin experienced:

- Improved PSA control (0.20 vs 0.08 events/year; p=0.003)[1,2]

- A significantly lower rate of PSA failure or death[1,2]

- Tolerability of FIRMAGON(R) was maintained throughout the extended study period[1,2]

"The data from the ongoing extension study demonstrated that the efficacy of FIRMAGON(R) remains strong over the long term, providing prostate cancer patients with sustained PSA control," said Professor Laurent Boccon-Gibod, Professor of Urology, Centre Hospitalo-Universitaire Bichat, Paris. "This is further evidence of the benefits of starting and staying on FIRMAGON(R) and that FIRMAGON(R) can be used as a first-line androgen deprivation therapy for advanced hormone-dependent prostate cancer patients."