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9 May 2014

NICE Issues Positive Recommendation for Xtandi (Enzalutamide)

The National Institute for Health and Care Excellence (NICE) has issued a Final Appraisal Determination (FAD) recommending Xtandi (enzalutamide) within its marketing authorisation as an option for the treatment of metastatic hormone-relapsed prostate cancer in adults whose disease has progressed during or after docetaxel containing chemotherapy[i]. 


This announcement follows issuance of a first Appraisal Consultation Document (ACD) in October 2013[ii] and a second one in January 2014[iii]. The latter ACD included a restriction on the use of enzalutamide post-abiraterone[iii], which, following consultation, has been removed[i].


“I am delighted with this decision from NICE   — this is great news for clinicians and will benefit many patients” comments Dr Heather Payne, Consultant in Clinical Oncology at University College Hospital. “Enzalutamide represents an important breakthrough in the management of this disease and has demonstrated survival benefit whilst offering patients improved quality of life. Metastatic castrate-resistant prostate cancer affects thousands of men in the UK and today’s FAD will allow patients access to a valuable treatment option on the NHS.”  

Prostate cancer is the most common cancer amongst males in England, with more than 34,000 new cases diagnosed annually, a proportion of whom will go on to develop castrate-resistant disease[iv]. The recommendation is based on data from the pivotal Phase III AFFIRM trial which demonstrated that treatment with enzalutamide improved overall survival by an average of 4.8 months compared to placebo — a 37% reduction in the risk of death[v].   


Dr Alan McDougall, Medical Director at Astellas Pharma Ltd comments: “We welcome the latest decision by NICE, and are pleased that the restriction in the second ACD has been removed. We believe that all appropriate patients who can benefit should have access to enzalutamide on the NHS which will allow clinicians to make the best treatment decision for their patients. ” 

Marketing Authorisation was granted to enzalutamide within Europe in June, 2013[vi]. In Scotland, enzalutamide is recommended within its licensed indication on the NHS following approval from the Scottish Medicines Consortium (SMC) in November 2013[vii]. Similarly with the pending issuance of this NICE Guidance in June, enzalutamide will be recommended within its licensed indication, with NICE noting that the prior use of abiraterone is not covered by this guidance[i].



[i] The National Institute for Health and Care Excellence, FAD for enzalutamide, available at, last accessed May 2014.

[ii] The National Institute for Health and Care Excellence, first ACD for enzalutamide, available at, last accessed Jan 2014.

[iii] The National Institute for Health and Care Excellence, second ACD for enzalutamide, available at, last accessed April 2014.

[iv] Prostate Cancer UK, Prostate Cancer Facts and Statistics, available at, last accessed April 2014.

[v] Scher H I, et al. Increased Survival with Enzalutamide in Prostate Cancer after Chemotherapy, N Engl J Med 2012; 367:1187–1197.

[vi] European Medicines Agency, Xtandi (enzalutamide) Summary of Product Characteristics, available at 6.pdf last accessed April 2014.

[vii] SMC recommendation for enzalutamide (Xtandi), Scottish Medicines Consortium website, available at, last accessed April 2014.

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