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Extension Study With FIRMAGONŽ (degarelix) Showed Continued Benefits for Prostate Cancer Patients Beyond One Year

Tuesday, June 1, 2010 General News J E 4
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ANNOUNCED AT LEADING UROLOGY MEETING

SAN FRANCISCO, June 1 /PRNewswire/ -- Prostate cancer patients on leuprolide who were offered to continue on FIRMAGONŽ (degarelix for injection) after one year of treatment reduced prostate specific antigen (PSA) recurrence, according to results of a Phase III extension study(1) presented here at the American Urological Association 2010 meeting. PSA is commonly used in monitoring prostate cancer patients' treatment response, and a high PSA number may indicate prostate cancer presence or recurrence.  

Patients with all stages of prostate cancer were randomized to a FIRMAGONŽ starting dose of 240 mg, then monthly maintenance doses of 80 mg (n = 207) or 160 mg (n =202) or leuprolide 7.5 mg/month (n = 201). Bicalutamide could be given as flare protection to those being treated with leuprolide. After one year, all patients taking leuprolide were re-randomized to FIRMAGONŽ 240/80 mg or 240/160 mg treatment. PSA progression-free survival (PFS) was defined in this study as time to first PSA recurrence (two consecutive increases in PSA of 50% and greater than or equal to 5 ng/mL on two consecutive measurements at least two weeks apart compared with nadir).

Up to one year, patients receiving FIRMAGONŽ   had a statistically lower risk of PSA recurrence compared with leuprolide (p = 0.05; log-rank). Adjusting for baseline disease state and PSA resulted in a hazard ratio (HR) of 0.664 (95% CI, 0.385 – 1.146). Beyond 1 year, the PSA recurrence rate decreased in patients previously on leuprolide. As of October 2009, there was a significant PSA PFS hazard change, from 0.20 events/year in the first year to 0.09 in the same group of patients (p=0.006); the corresponding hazards for  FIRMAGONŽ  were 0.11 and 0.14. The same pattern of hazard change occurred in patients with a baseline PSA > 20ng/mL. Up to 1 year, there was a difference in arthralgias for patients treated with FIRMAGONŽ   vs. 9% for those patients treated with leuprolide. Beyond 1 year, the arthralgias were similar.

"These preliminary data are very encouraging to clinicians who treat patients with locally advanced and advanced prostate cancer; however, further studies are required to confirm these findings," said E. David Crawford, MD, who presented the data and serves as head of Urologic Oncology, University of Colorado Denver Health Sciences Center, and Practice Director for the Urologic Oncology Clinic.  "This study provides additional evidence that FIRMAGON is an effective initial and continuous option for advanced prostate cancer patients."

About the Study

Patients with histologically confirmed prostate cancer (all stages) were randomized to either a FIRMAGON starting dose of 240 mg, then monthly maintenance doses of 80 mg (n=207) or 160 mg (n=202), or to leuprolide 7.5 mg per month (n=201). After one year, patients receiving leuprolide were offered to receive degarelix 240/80 mg or 240/160 mg treatment. Up to one year, PSA progression-free survival (PFS) was significantly longer in the subjects receiving degarelix compared with leuprolide (p=0.0495).  

About FIRMAGON

FIRMAGONŽ (degarelix for injection) is a gonadotropin-releasing hormone (GnRH) receptor antagonist indicated 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(2) FIRMAGON also reduces levels of prostate-specific antigen (PSA).  Unlike luteinizing hormone-releasing hormone (LHRH) agonists, such as leuprolide, an established treatment for advanced prostate cancer, FIRMAGON does not induce an initial testosterone surge. FIRMAGON is administered monthly by subcutaneous injection.  The starting dose is 240 mg, followed by monthly maintenance doses of 80 mg. FIRMAGON is available for order through traditional and specialty pharmacy distributors. The average monthly cost of one year of FIRMAGON treatment is comparable to other hormone treatments for advanced prostate cancer.

Important Safety Information

FIRMAGON is contraindicated in patients with known hypersensitivity to degarelix or to any of the product components. FIRMAGON is not indicated in women or pediatric patients.  

Long-term androgen deprivation therapy prolongs the QT interval. Physicians should consider whether the benefits of androgen deprivation therapy outweigh the potential risks in patients with congenital long QT syndrome, electrolyte abnormalities, or congestive heart failure and in

patients taking Class IA (e.g. quinidine, procainamide) or Class III (e.g. amiodarone, sotalol) antiarrhythmic medications. The most commonly observed adverse reactions during FIRMAGON therapy included injection site reactions (e.g. pain, erythema, swelling or induration), hot flashes, increased weight, fatigue, and increases in serum levels of transaminases and gamma-glutamyltransferase (GGT). Ninety-nine percent of these observed adverse reactions were Grade 1 or 2 (mild to moderate). Specifically relating to the injection site adverse reactions, most were transient, of mild to moderate intensity, occurred primarily with the starting dose and led to few discontinuations (<1%). Grade 3 (severe) injection site reactions occurred in two percent or less of patients receiving FIRMAGON.  

About Prostate Cancer

Prostate cancer is the most common cancer, excluding skin cancers, and the second leading cause of cancer death in American men. About one man in six will be diagnosed with

prostate cancer during his lifetime, and one in 35 will die of this disease(3) Prostate cancer develops from cells in the prostate gland that begin to undergo abnormal changes. In most cases, prostate cancer grows slowly and can remain undetected throughout a man's life, although it can grow and spread quickly.(4) The four types of standard treatment are: watchful waiting, surgery, radiation therapy, and hormone therapy, also called androgen deprivation therapy (ADT).(5)  

About Ferring Pharmaceuticals Inc.

Ferring Pharmaceuticals Inc. is a subsidiary of Ferring Pharmaceuticals, a privately owned, Swiss biopharmaceutical company.  Ferring Pharmaceuticals specializes in the research, development and commercialization of peptide compounds in urology,   gastroenterology, obstetrics/gynecology, and infertility.  Ferring Pharmaceuticals offers a line of urology, infertility, gynecology, and orthopaedic products in the U.S. market.  For more information, call 1-888-FERRING (1-888-337-7464) or visit www.FerringUSA.com.

REFERENCES

  1. Crawford ED et al. Switching from leuprolide to degarelix vs continuous degarelix treatment – effects on long-term prostate-specific antigen control. J Urol suppl. May 29, 2010.
  2. Doehn C. Immunotherapy of Prostate Cancer. Eur Uro. 2008;53-4:681-683.
  3. American Cancer Society.  How Many Men Get Prostate Cancer? Available at: http://www.cancer.org/docroot/CRI/content/CRI_2_2_1X_How_many_men_get_prostate_cancer_36.asp?sitearea=. Accessed 21 May 2010.
  4. American Cancer Society.  What is prostate cancer? Available at: http://www.cancer.org/docroot/CRI/content/CRI_2_4_1X_What_is_prostate_cancer_36.asp. Accessed 24 May 2010.
  5. American Cancer Society. How Is prostate cancer treated? Available at: http://www.cancer.org/docroot/CRI/content/CRI_2_4_4X_How_is_prostate_cancer_treated_36.asp?rnav=cri. Accessed 24 May 2010.

SOURCE Ferring Pharmaceuticals Inc.

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