This positive assessment by the European Committee for Medicinal Products for Human Use (CHMP) is now 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.**
Today’s 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.***
Professor de Bono says: “We are thrilled that the regulator has recommended Zytiga be granted marketing approval throughout Europe. Men with advanced 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.”
ICR Chief Executive Professor Alan Ashworth says: “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 says: “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.”
Notes to editors:
* The Committee for Medical Products for Human Use (CHMP) of the European Medicines Agency (EMA) has given a positive opinion recommending the approval of abiraterone acetate, a once daily oral medication used – in combination with prednisone or prednisolone – for the treatment of metastatic castration-resistant prostate cancer in adult men whose disease has progressed on or after a docetaxel-based chemotherapy regimen. The CHMP opinion is now referred for approval to the European Commission, who have final authority over granting marketing approval throughout the EU, including the UK. The US Food and Drug Administration approved the drug for use in the US in April 2011.
** Abiraterone acetate was invented by Professor Mike Jarman and his colleagues in what is now the Cancer Research UK Cancer Therapeutics Unit at the ICR in Sutton, south of London, in research supported by grants from Cancer Research Campaign (now Cancer Research UK), the Medical Research Council (MRC) and BTG International LTD.
Professor Johann de Bono from the ICR and The Royal Marsden led the Phase I and II clinical trials at the Royal Marsden and the pivotal Phase III multi-centre trial. Further research and trials on abiraterone acetate were 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, The Prostate Cancer Charity, the ICR and The Royal Marsden. Abiraterone acetate was assigned to BTG International Ltd, who in turn licensed it to Ortho Biotech Oncology Research & Development, a unit of Cougar Biotechnology Inc., now a member of the Janssen Pharmaceutical Companies.
*** The randomised, double-blind placebo-controlled trial sponsored by Ortho Biotech Oncology Research & Development, a Unit of Cougar Biotechnology, Inc., began in May 2008 and was conducted in 147 sites in 13 countries. The 1,195 men who enrolled in the trial had all stopped responding to standard hormone therapy as well as second-line treatments including the chemotherapy drug docetaxel. They were either given abiraterone acetate together with the steroid prednisone (797 men), or prednisone and a placebo (398 men). The study showed that men given the placebo survived an average of 11 months, while men given abiraterone acetate survived for nearly 15 months.
Abiraterone and Increased Survival in Metastatic Prostate Cancer published in the New England Journal of Medicine on May 25, 2011. www.nejm.org/doi/full/10.1056/NEJMoa1014618
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
- Professor Colin Cooper is the Grand Charity of Freemasons Professor of Molecular Biology. Professor Ros Eeles is Professor in Oncogenetics at the ICR and an Honorary Consultant in Clinical Oncology and Cancer Genetics at The Royal Marsden
For more information visit www.icr.ac.uk
The Royal Marsden opened 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