European Approval for UK-Discovered Prostate Cancer Drug

A drug that extends life for men with advanced prostate cancer, developed at The Institute of Cancer Research (ICR) and The Royal Marsden Hospital, has today been approved for use throughout Europe.

Following a fast-track review process, the European Commission has authorised abiraterone acetate, from Janssen-Cilag International NV under the trade name ZYTIGA®, for the treatment of metastatic “castration-resistant” prostate cancer in adult men whose disease has progressed on or after a docetaxel-based chemotherapy regimen. Abiraterone acetate tablets are taken once a day in combination with the steroids prednisone or prednisolone.

Abiraterone acetate is a new type of treatment for prostate cancer that works by blocking the synthesis of testosterone in all tissues including the tumour itself, not just the testes. This testosterone would otherwise continue to 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.

The ICR’s Chief Executive Alan Ashworth says: “ZYTIGA’s approval is great news for the 90,000 men who sadly succumb to prostate cancer in Europe each year. We are thrilled and proud that The Institute of Cancer Research has led the way in bringing this important prostate cancer drug to market. Academic research organisations are playing a vital role in drug discovery and development and this clearly demonstrates the critical need for ongoing funding and support.”

Royal Marsden Chief Executive Cally Palmer says: “We welcome the news from the European Commission and look forward to further developing this promising drug. The development of abiraterone by The Royal Marsden and the ICR highlights the national importance of funding pioneering cancer research."

Today’s decision was based largely on data from an international Phase III clinical trial of almost 2,000 men in 13 countries jointly led by Professor Johann de Bono from the ICR and The Royal Marsden. Patients with advanced prostate cancer who were given abiraterone acetate on the trial lived on average 15.8 months compared to 11.2 months for men taking a placebo. Pain also eased for a much greater proportion of patients taking abiraterone, while side-effects were easily manageable and reversible.

Professor de Bono says: “Men with advanced prostate cancer have very few treatment options available to them and new therapies such as this are desperately needed.

Abiraterone acetate is a once-a-day tablet with manageable side-effects that has been shown in clinical trials to extend life for men with advanced prostate cancer and importantly can improve quality of life. This drug gives doctors a valuable new treatment option and could make a huge difference to men suffering from this devastating disease.”

Cancer Research UK’s CEO Harpal Kumar says: “We're very pleased to see that abiraterone has been licensed for use by the European Commission, especially given the role Cancer Research UK played in the early stages of its discovery and development. This highlights the importance of investment into cancer research. Once approved, abiraterone could help improve survival from aggressive forms of advanced prostate cancer.”

The UK launch of abiraterone is anticipated in the near future.