WEST DRAYTON, England -- Recommendation comes 36 months after NICE review was first announced
Ferring Pharmaceuticals announced that the National Institute for Health and Care Excellence (NICE) has recommended FIRMAGON® (degarelix) for a group of men with advanced hormone-dependent prostate cancer - those with spinal metastases. This announcement comes after a review process lasting over 3 years, and follows NICE's most recent draft Appraisal Consultation Document (ACD) published in June 2015, which recommended against the use of FIRMAGON® within its marketing authorisation for treating advanced hormone-dependent prostate cancer.
Ferring UK's General Manager, Steve Howson, commented: "NICE's decision represents a significant step forward, and is very good news for men living with advanced hormone-dependent prostate cancer, who are in need of rapid control of their condition. This has been a long process but throughout these last 3 years we have maintained our firm belief that FIRMAGON® can have a significant impact on patients' lives. We are delighted that our belief will now be realised across the UK."
FIRMAGON® was first approved by the European Medicines Agency for men with advanced hormone-dependent prostate cancer in 2009, and has been available in the UK since 2010. The ongoing changes to NICE's guidance since then have resulted in great variations in access to FIRMAGON® across the UK, and between regions in England and Northern Ireland. The use of FIRMAGON® has been recommended in Scotland and Wales for several years for its full indication.,
"It is great news for patients with advanced hormone-dependent prostate cancer that FIRMAGON® has finally been approved by NICE," said Professor Roger Kirby, Professor of Urology, University of London, UK. "As a urologist, I am pleased that this rapidly acting and effective treatment is now available for men whose disease has spread to the spine."
Testosterone-lowering therapy is considered a primary treatment for prostate cancer. In clinical studies, FIRMAGON® demonstrated an immediate reduction in testosterone levels upon initial use, achieving clinically significant levels within 3 days. Maintenance therapy with FIRMAGON® led to long-term testosterone suppression for up to 5 years. FIRMAGON® has shown significantly longer progression-free survival, compared with luteinising hormone-releasing hormone (LHRH) agonists, an existing hormonal therapy. Furthermore, clinical studies have demonstrated that men treated with FIRMAGON® have a significantly reduced risk of cardiovascular disease, fewer musculoskeletal events and a lower incidence of urinary tract events than those treated with LHRH agonists., Treatment with FIRMAGON® has also demonstrated a more rapid reduction in prostate-specific antigen (PSA); a significant reduction in the risk of PSA progression, compared with existing hormonal therapies; and a better control of serum alkaline phosphatase (S-ALP), which is indicative of tumour activity within bones.
Rowena Bartlett, Chief Executive, Tackle Prostate Cancer, commented: "The revised NICE recommendation means that those men living with advanced hormone-dependent prostate cancer now have a significantly better chance of receiving this important therapy. Prostate cancer is still one of the lead killers of men living in the UK, and there is a need for much greater urgency in making treatments available. This decision also comes at a particularly challenging time for prostate cancer treatment in the UK, with access to cancer drugs in England becoming increasingly impacted by cuts to the Cancer Drugs Fund."
FIRMAGON® (degarelix) is an antagonist form of androgen deprivation therapy that reversibly binds to the GnRH receptors, inhibiting the production of testosterone immediately. FIRMAGON® was approved for the treatment of advanced hormone-dependent prostate cancer in the US in 2008, and in the EU in 2009. Today, it is available in approximately 53 countries around the world, including a growing number in Asia, Latin America and the Middle East.
About prostate cancer:
Prostate cancer is the most common cancer in men in the UK, and approximately 1 in 8 men develop the disease at some point in their lives. In the UK, one man dies from prostate cancer every hour - equivalent to more than 10,800 every year. Over 47,000 men are diagnosed with prostate cancer every year across the UK, which equates to around 130 men per day - this represents approximately 40,000 men in England, 3,000 in Scotland, 2,500 in Wales and 1,000 in Northern Ireland.
All Wales Medicines Strategy Group. Final appraisal recommendation. Degarelix (Firmagon®) 80 mg and 120 mg subcutaneous injection. Available at: http://www.awmsg.org/awmsgonline/app/appraisalinfo/755 . Accessed July 2016.
Scottish Medicines Consortium. Degarelix 120mg and 80mg powder and solvent solutions for injection (Firmagon®). Available at: https://www.scottishmedicines.org.uk/SMC_Advice/Advice/560_09_degarelix_Firmagon/degarelix__Firmagon_Resubmission - Accessed July 2016.
European Association of Urology. Prostate Cancer Guidelines. Available at: https://uroweb.org/guideline/prostate-cancer/#6_5 - Accessed July 2016.
Klotz L et al. The efficacy and safety of degarelix: a 12-month, comparative, randomized, open-label, parallel-group phase III study in patients with prostate cancer. BJU Int 2008;102:1531-8.
Crawford ED et al. Long-term tolerability and efficacy of degarelix: 5-year results from a phase III extension trial with a 1-arm crossover from leuprolide to degarelix. Urology 2014;83:1122-8.
Schröder FH et al. Changes in alkaline phosphatase levels in patients with prostate cancer receiving degarelix or leuprolide: results from a 12-month, comparative, phase III study. BJU Int 2010;106:182-7.
Klotz L et al. Disease control outcomes from analysis of pooled individual patient data from five comparative randomised clinical trials of degarelix versus luteinising hormone-releasing hormone agonists. Eur Urol 2014;66:1101-8.
Albertsen PC et al. Olesen TK, Nilsson J. Cardiovascular morbidity associated with gonadotropin releasing hormone agonists and an antagonist. Eur Urol 2014;65:565-73.
Tombal B et al. Additional analysis of the secondary end point of biochemical recurrence rate in a phase 3 trial (CS21) comparing degarelix 80 mg versus leuprolide in prostate cancer patients segmented by baseline characteristics. Eur Urol 2010;57:836-42.
Prostate Cancer UK. About Prostate Cancer. Available at: http://prostatecanceruk.org/prostate-information/about-prostate-cancer - Accessed July 2016.