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.
Media Contact: Science Communications Manager Jane Bunce on 0207 153 5106 or after hours 077217 47900
Notes to editors:
* Abiraterone was discovered at the ICR in research supported by grants from Cancer Research Campaign (now Cancer Research UK), the Medical Research Council (MRC) and BTG International LTD. Subsequent patient trials and further research on abiraterone was supported by Cougar Biotechnology Inc. / Janssen Pharmaceutical Companies, Cancer Research UK, Experimental Cancer Medicine Centre, the MRC, BTG International Ltd, Prostate Cancer Foundation, Prostate Cancer Research Foundation, Prostate Cancer Charity, the ICR and The Royal Marsden. Cancer Research Technology assigned abiraterone acetate to BTG International Ltd, who in turn licensed it to Cougar Biotechnology Inc., now a member of the Janssen Pharmaceutical Companies.
The Institute of Cancer Research (ICR)
- The ICR is Europe’s leading cancer research centre
- The ICR has been ranked the UK’s top academic research centre, based on the results of the Higher Education Funding Council’s Research Assessment Exercise
- The ICR works closely with partner The Royal Marsden NHS Foundation Trust to ensure patients immediately benefit from new research. Together the two organisations form the largest comprehensive cancer centre in Europe
- The ICR has charitable status and relies on voluntary income
- As a college of the University of London, the ICR also provides postgraduate higher education of international distinction
- Over its 100-year history, the ICR’s achievements include identifying the potential link between smoking and lung cancer which was subsequently confirmed, discovering that DNA damage is the basic cause of cancer and isolating more cancer-related genes than any other organisation in the world
- The ICR is home to the world’s leading academic cancer drug development team. Several important anti-cancer drugs used worldwide were synthesised at the ICR and it has discovered an average of two preclinical candidates each year over the past five years.
For more information visit www.icr.ac.uk The Royal Marsden
The Royal Marsdenopened its doors in 1851 as the world’s first hospital dedicated to cancer diagnosis, treatment, research and education.
Today, together with its academic partner, The Institute of Cancer Research (ICR), it is the largest and most comprehensive cancer centre in Europe treating over 44,000 patients every year. It is a centre of excellence with an international reputation for groundbreaking research and pioneering the very latest in cancer treatments and technologies. The Royal Marsden also provides community services in the London boroughs of Sutton and Merton and in June 2010, along with the ICR, the Trust launched a new academic partnership with Mount Vernon Cancer Centre in Middlesex.
Since 2004, the hospital’s charity, The Royal Marsden Cancer Charity, has helped raise over £50 million to build theatres, diagnostic centres, and drug development units. Prince William became President of The Royal Marsden in 2007, following a long royal connection with the hospital.
For more information, visit www.royalmarsden.nhs.uk
About Cancer Research UK
- Cancer Research UK is the world’s leading cancer charity dedicated to saving lives through research
- The charity’s groundbreaking work into the prevention, diagnosis and treatment of cancer has helped save millions of lives. This work is funded entirely by the public.
- Cancer Research UK has been at the heart of the progress that has already seen survival rates double in the last forty years.
- Cancer Research UK supports research into all aspects of cancer through the work of over 4,000 scientists, doctors and nurses.
- Together with its partners and supporters, Cancer Research UK’s vision is to beat cancer.
For further information about Cancer Research UK’s work or to find out how to support the charity, please call 020 7121 6699 or visit www.cancerresearchuk.org