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The Institute of Cancer Research (ICR) and The Royal Marsden have welcomed the European pharmaceutical regulator’s recommendation that abiraterone acetate (trade name Zytiga™, manufactured by Janssen Pharmaceutical Companies) be approved for use in men with castration-resistant metastatic prostate cancer who have received prior docetaxel chemotherapy.
This positive assessment by the European Committee for Medicinal Products for Human Use (CHMP) has now been referred to the European Commission for sign-off in what could be the final step before UK men suffering from this very advanced form of prostate cancer can access the drug.
Abiraterone acetate is a new type of treatment for prostate cancer that works by blocking the synthesis of testosterone in all tissues, not just the testes. Normally, this testosterone would fuel prostate cancer growth and spread.
Abiraterone was discovered at the ICR in what is now the Cancer Research UK Cancer Therapeutics Unit, and further developed at the ICR and The Royal Marsden.
This recommendation was based largely on data from a Phase III clinical trial jointly led by Professor Johann de Bono from the ICR and The Royal Marsden, which demonstrated an increased overall survival for men with castration-resistant metastatic prostate cancer.
“We are thrilled that the regulator has recommended Zytiga™ be granted marketing approval throughout Europe,” said de Bono.
“Men with metastatic prostate cancer have very few treatment options available to them and new therapies such as this are desperately needed. If the European Commission supports this positive opinion, it could make a huge difference to the 10,000 men diagnosed with aggressive late stage forms of prostate cancer in the UK every year.”
The ICR Chief Executive Professor, Alan Ashworth, added: “Since we first discovered this drug, the ICR, together with our partners, has worked relentlessly to develop abiraterone acetate into a well-tolerated, effective treatment for men with advanced prostate cancer.
“It is highly exciting and satisfying to be so close to a decision that could mean thousands of men with this disease benefit from our work.”
Royal Marsden Chief Executive Cally Palmer said: “We welcome the news from the regulator and look forward to further developing this promising drug.
“This drug is a major progression in the treatment of prostate cancer and offers new therapeutic perspectives for men with advanced prostate cancer. The work done so far between The Royal Marsden and the ICR highlights the national importance of funding pioneering cancer research.”