XTANDI now accepted for use within NHS Scotland for treatment of adult men with mCRPC

Prostate Cancer affects 1 in 12 Scottish men and is the most common cancer amongst men in Scotland.

The Scottish Medicines Consortium (SMC), which advises NHS Scotland on prescribing new treatments, announced today that XTANDI™ (enzalutamide) is accepted for unrestricted use within NHS Scotland for the treatment of adult men with metastatic castration-resistant prostate cancer (mCRPC) whose disease has progressed on or after docetaxel therapy. Prostate cancer affects over 2,500 people in Scotland per year. Around 10-20% of patients develop advanced (or metastatic) prostate cancer within approximately 5 years of follow-up from diagnosis.

Commenting on the SMC decision Dr. Rob Jones, Senior Lecturer and Honorary Consultant in Medical Oncology, University of Glasgow, said: “Today marks a great day for Scottish patients with metastatic prostate cancer. Enzalutamide has demonstrated its ability to prolong life, whilst also improving the quality of life for those with this form of the disease. Today’s announcement from the SMC is a notable milestone for the management of metastatic castration-resistant prostate cancer and paves the way for more men to be given precious extra months at a stage of life when time and quality of life is so cherished. I would specifically like to thank all those Scottish patients who took part in the trials of this drug and others like it that made this moment possible.”

Today’s approval from the SMC is based on results of the pivotal Phase III AFFIRM study. Trialled in various countries across Europe, including Scotland, enzalutamide patients had a 37% reduction in the risk of death and an improved overall survival on average of 4.8 months compared to placebo. 

The recommendation from the SMC means that all eligible patients can receive enzalutamide irrespective of number of previous cycles of chemotherapy. 

Rob Lester, Chairman of the Edinburgh & Lothian Prostate Cancer Support Group commented: “Patients and their families will be glad to see that enzalutamide is now freely obtainable to all those eligible for therapy. In recent years, the number of people diagnosed with prostate cancer in Scotland has increased and now many men and their families are affected year-on-year - today’s news brings fresh hope for these individuals. We look forward to a time when more men with advanced prostate cancer are eligible for this treatment.” 

Different to other treatments for metastatic prostate cancer, enzalutamide works at three steps in the androgen receptor signalling pathway within the cancer cells, stopping the cancer growing. In these patients enzalutamide has been shown to decrease cancer cell growth and can cause cancer cell death.

Enzalutamide is a once-daily, oral treatment administered without the need for routine product-specific monitoring. Steroids are not required to be taken with enzalutamide; however, they can be prescribed at the judgement of a doctor. 

The SMC is the first health technology appraisal body in the UK to approve enzulatamide for NHS patients. Last month enzalutamide received a draft positive recommendation from NICE, with final guidance expected February 2014.