Xtandi (enzalutamide) from Astellas is licensed for patients in whom advanced prostate cancer is resistant to first-line hormonal treatments and has progressed following chemotherapy.
The new medicine has been shown to improve overall survival by 4.8 months relative to placebo.
Prostate cancer is the most common cancer among men, affecting 40,000 new patients per year.
Advanced (metastatic) prostate cancer is incurable, and 72% of patients die within three years of diagnosis.
Xtandi is a daily oral medication that reduces cancer cell growth and can cause cancer cell death. It takes effect at three distinct steps in the androgen receptor signalling pathway within cancer cells.
The UK approval is based on the results of the AFFIRM trial, a multinational study comparing Xtandi with placebo in 1,199 men with advanced prostate cancer who had received chemotherapy.
Professor Johann de Bono, Consultant Medical Oncologist at the Royal Marsden NHS Foundation Trust, 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.”
Astellas Pharma Europe, based in the UK, is a European subsidiary of the Japanese company Astellas Pharma Inc.