Navigation Links
Extension Study With FIRMAGON® (degarelix) Showed Continued Benefits for Prostate Cancer Patients Beyond One Year
Date:6/1/2010

SAN FRANCISCO, June 1 /PRNewswire/ -- Prostate cancer patients on leuprolide who were offered to continue on FIRMAGON® (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 FIRMAGON® 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 FIRMAGON® 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 FIRMAGON®   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  FIRMAGON®  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 FIRMAGON®   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

FIRMAGON® (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.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. NYSE Amex Provides Interleukin Genetics, Inc. Extension To Meet Continued Listing Standards
2. Amicus Therapeutics Presents Positive Data Update From Phase 2 Extension Study of Amigal(TM) for Fabry Disease
3. Maxygen, Inc. Announces Extension of Dutch Auction Tender Offer
4. Dynatronics Receives 180-Day NASDAQ Extension
5. Heska Announces Extension of Credit Agreement With Wells Fargo
6. Quigley CEO, Ted Karkus, Announces Phase One of 2010 Strategic Plan; Karkus Reports that the Primary Focus will be on Leveraging its OTC Platform; Company Aggressively Seeking Product Acquisitions and Line Extensions which Leverage its Distribution
7. Galenea and Otsuka Announce Second Extension to Schizophrenia Research Collaboration
8. Par Pharmaceutical Announces Extension and Increase in Maximum Purchase Price for Modified Dutch Auction Tender Offer to Purchase up to $65,000,000 Aggregate Principal Amount of its Currently Outstanding 2.875% Senior Subordinated Convertible Note
9. Long-Term Data Updates Show Further Extensions of Survival and Delays in Recurrence in Brain Cancer Patients Who Received DCVax(R)-Brain
10. EPIX Pharmaceuticals Announces FDA Approval of a Physician-Sponsored IND for Fourth 6-month Open Label Extension of PRX-03140 for Alzheimers Disease Patient
11. Catalyst Pharmaceutical Partners, Inc. Announces Organizational Changes and Extension of Chief Executives Employment Agreement
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/24/2016)...   Pulmatrix, Inc ., (NASDAQ: PULM ... announced today that it was added to the Russell ... comprehensive set of U.S. and global equity indexes on ... milestone for Pulmatrix," said Chief Executive Officer Robert ... progress in developing drugs for crucial unmet medical needs, ...
(Date:6/23/2016)... Research and Markets has announced the addition of ... report to their offering. ... kidney failure, it replaces the function of kidneys by removing ... thus the treatment helps to keep the patient body,s electrolytes ... Increasing number of ESRD patients & substantial healthcare expenditure ...
(Date:6/23/2016)... , June 23, 2016 Roche (SIX: ... 510(k) clearance for its Elecsys BRAHMS PCT (procalcitonin) assay ... sepsis or septic shock. With this clearance, Roche is ... a fully integrated solution for sepsis risk assessment and ... with bacterial infection and PCT levels in blood can ...
Breaking Medicine Technology:
(Date:6/26/2016)... ... ... PawPaws brand pet supplements owned by Whole Health Supply is ... of felines. The formula is all-natural and is made from Chinese herbs that have ... Kidney Support Supplement Soft Chews are Astragalus Root Extract and Rehmannia Root Extract ...
(Date:6/25/2016)... , ... June 25, 2016 , ... ... policy issues and applications at AcademyHealth’s Annual Research Meeting June 26-28, 2016, at ... on several important health care topics including advance care planning, healthcare costs and ...
(Date:6/25/2016)... (PRWEB) , ... June 25, 2016 , ... "With 30 ... their specific project," said Christina Austin - CEO of Pixel Film Studios. , ... and all within Final Cut Pro X . Simply select a ProHand generator ...
(Date:6/25/2016)... ... June 25, 2016 , ... Dr. ... from injury. Recently, he has implemented orthobiologic procedures as a method for treating ... one of the first doctors to perform the treatment. Orthobiologics are substances that ...
(Date:6/24/2016)... (PRWEB) , ... June 24, 2016 , ... A recent ... that most people are unfamiliar with. The article goes on to state that individuals ... also many of these less common operations such as calf and cheek reduction. The ...
Breaking Medicine News(10 mins):