Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 12 Jul 2013 - 2:00 PDT Current ratings for:
New Treatment For Management Of Advanced Prostate Cancer After First-Line Hormonal Treatments And Docetaxel Chemotherapy Failure, Available In UK
Available now, XTANDI TM (enzalutamide) has been licensed for the treatment of men with advanced prostate cancer whose disease has become resistant to first-line hormonal treatments and has progressed following docetaxel chemotherapy[i], marking an important step in managing prostate cancer, which is the most common cancer among males in the UK.[ii] The UK licence has been granted based on pivotal trial data showing a 37% reduction of the risk of death versus placebo for patients taking enzalutamide during the study.[iii] Enzalutamide was also shown to be generally well tolerated.[iii] Enzalutamide is the latest in a new generation of drugs which can prolong and improve the quality of life for men with incurable advanced prostate cancer.[iii]
Professor Johann de Bono, Professor of Experimental Cancer Medicine at The Institute of Cancer Research, London, and Consultant Medical Oncologist at The Royal Marsden NHS Foundation Trust, and Global Chief Investigator in the AFFIRM trial said: "Enzalutamide is a much needed development in prostate cancer treatment and will provide a new option for the increasing number of men with advanced prostate cancer in the UK, whose disease has become resistant to first-line hormonal treatments and who have had docetaxel chemotherapy. Enzalutamide has already demonstrated a positive impact on quality of life whilst increasing the life-span of patients with this common disease. Its use will bring significant benefits, establishing it as a key component of advanced prostate cancer treatment in the UK."
Prostate cancer is the second most common cause of cancer death in men in the UK.[ii] Although early stage disease can often be cured, when prostate cancer spreads to other parts of the body (known as advanced or metastatic prostate cancer), most commonly the bones, the disease is incurable.[iv] In patients who present with advanced disease, 72% will die within 5 years of diagnosis.[v]
Many men with advanced disease eventually develop resistance to first-line hormone treatment; this is called castration-resistant prostate cancer (CRPC).[vi] On average, 10-20% of prostate cancer patients develop CRPC within approximately 5 years of follow up, and of those almost 84% have metastatic disease at the time of diagnosis.[vii]
Enzalutamide is a once-daily, oral treatment administered without the need for routine product- specific monitoring.i Steroids are not required to be taken with enzalutamide, however, they can be prescribed at the judgement of a doctor.[i]
Enzalutamide works differently from other treatments for patients with advanced prostate cancer: enzalutamide works at three steps in the androgen receptor (AR) signalling pathway within the cancer cells stopping the cancer growing.[i] In advanced prostate cancer enzalutamide has been shown to decrease cancer cell growth and can cause cancer cell death.[i,iii]
The granting of the UK licence for enzalutamide follows the submission of data from the AFFIRM trial - a multinational study evaluating enzalutamide (160 mg/day) versus placebo in 1,199 men with advanced prostate cancer who were previously treated with docetaxel-based chemotherapy.[iii] From today, enzalutamide will provide UK clinicians with a treatment option which improves overall survival by an average of 4.8 months versus placebo, whilst potentially helping to maintain a good quality of life.i,iii Enzalutamide is available in England via the Cancer Drugs Fund.[viii]
About advanced prostate cancer
Advanced (or metastatic) prostate cancer refers to a cancerous tumour which has extended beyond the prostate and moved to other parts of the body, most commonly the bones.[ix,x] These 'advanced' prostate tumours cannot be cured.iv Treatment of advanced prostate cancer usually involves reducing testosterone either by surgical or medical methods.iv However, advanced prostate cancer can become resistant to this type of therapy at which stage it is known as metastatic castration- resistant prostate cancer (mCRPC).[xi] When prostate cancer is advanced, treatment can usually be given to slow the progression of the cancer, relieve symptoms and improve quality of life.[xii]
About enzalutamidei
Enzalutamide is a novel, oral, once-daily androgen receptor signalling inhibitor which works in three distinct ways: it inhibits 1) testosterone binding to androgen receptors; 2) nuclear translocation of androgen receptors; and 3) DNA binding and activation by androgen receptors.
Enzalutamide is licensed in Europe for the treatment of adult men with mCRPC whose disease has progressed on or after docetaxel therapy.[i]
Enzalutamide was licensed by the U.S. Food and Drug Administration on August 31, 2012 for the treatment of patients with mCRPC who have previously received docetaxel therapy.[xiii]
About AFFIRM[iii]
The phase III AFFIRM trial is a randomised, double-blind, placebo-controlled, multinational trial evaluating enzalutamide (160 mg/day) versus placebo in 1,199 men with progressive mCRPC who were previously treated with docetaxel-based chemotherapy. Enrolment was completed in November 2010 and the interim analysis was triggered at 520 events. The median age of study participants was 69 years at baseline.
The AFFIRM study was conducted at sites in the United States, Canada, Europe, Australia, South America and South Africa.
Article adapted by Medical News Today from original press release. Click 'references' tab above for source.Visit our prostate / prostate cancer section for the latest news on this subject.
References
[i] European Medicines Agency, Xtandi (enzalutamide) Summary of Product Characteristics, 2013
[ii] Cancer Research UK, Prostate Cancer, available at http://publications.cancerresearchuk.org/downloads/Product/CS_KF_PROSTATE.pdf, last accessed May 2013
[iii] Scher H I, et al. Increased Survival with Enzalutamide in Prostate Cancer after Chemotherapy, New England Journal of Medicine, N Engl J Med 2012; 367:1187-1197
[iv] Cancer Research UK, Treatment options for prostate cancer, last accessed June 2013
[v] National Cancer Institute, SEER Fast Statistics, last accessed June 2013.
[vi] Macmillan Cancer Support. Treatment for advanced prostate cancer/hormonal therapy, last accessed June 2013
[vii] Kirby M, Hurst C, Crawford ED. Characterising the castration-resistant prostate cancer. Int J Clin Pract 2011;65:1180-92
[viii] NHS England, National Cancer Drugs Fund List, updated June 18th 2013, last accessed June 2012
[ix] Prostate cancer UK, what is advanced prostate cancer?, last accessed May 2013
[x] Cancer Research UK: The Stages of Prostate Cancer, last accessed June 2013
[xi] Maluf, F,Smaletz O, Herchenhorn, D, Castration-resistant prostate cancer: systemic therapy in 2012, last accessed June 2013 ?
[xii] Macmillan Cancer Support. Treatment for advanced prostate cancer, last accessed June 2013
[xiii] FDA, Xtandi (enzalutamide), prescribing information, 2012
Astellas
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14 Jul. 2013.
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