UK-discovered prostate cancer drug launched in Britain

A life-extending new drug to treat patients with advanced prostate cancer, developed by The Institute of Cancer Research (ICR) and The Royal Marsden Hospital, has received its UK license.

Abiraterone acetate, marketed by Janssen under the trade name ZYTIGA, has been shown in clinical trials to prolong survival for men with advanced prostate cancer. An estimated 10,500 men in the UK have advanced prostate cancer that has become resistant to standard hormone treatments.

The once-daily pill officially launches in the UK today after the European Commission earlier this month approved it for the treatment of metastatic prostate cancer. Abiraterone acetate was licensed for use in combination with the steroids prednisone or prednisolone, by men whose disease has developed resistance to conventional hormone therapies and docetaxel-based chemotherapy.

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 Professor Alan Ashworth says: “This drug was discovered in the UK at The Institute of Cancer Research. Its launch is the culmination of immense hard work and dedication by scientists and clinicians here and around the world. To have reached the point where thousands of prostate cancer patients will be able to benefit from this life-extending treatment is hugely rewarding.”

Royal Marsden Chief Executive Cally Palmer says: “The development of abiraterone by The Royal Marsden and the ICR highlights the national importance of funding pioneering cancer research. We are delighted our patients at The Royal Marsden have been among the first to benefit from the very latest in drug development.”

Results of a major international Phase III trial of almost 2,000 men jointly led by Professor Johann de Bono from the ICR and The Royal Marsden showed that patients given abiraterone acetate lived on average 15.8 months compared to 11.2 months for men taking a placebo. Pain also eased for a higher proportion of patients taking abiraterone, while side-effects were easily manageable and reversible.

When John Ward, 68 from West Dulwich, was diagnosed with prostate cancer nine years ago it had already spread to his spine, and doctors told him he had only one or two years to live. He started taking abiraterone in 2007 and is still healthy enough to continue working in the film industry. “I don’t think I would be alive today if it wasn’t for abiraterone. I’m still doing very well on it after nearly four-and-a-half years,” Mr Ward said.

Professor Johann de Bono said: “Prostate cancer kills one man each hour in the UK so there is a need for new therapies. As a doctor, I’m pleased to have this important new treatment option available for my patients who are no longer responding to standard drugs.”

Harpal Kumar, Cancer Research UK’s CEO, said: “We're delighted to see that abiraterone is now available in the UK especially given the role Cancer Research UK played in the early stages of its development. It could help treat the 10,000 men diagnosed with aggressive forms of advanced prostate cancer in the UK each year.

“NICE must now decide as quickly as possible whether the drug should be made routinely available to all appropriate patients. Meanwhile, decisions about whether patients can be given this drug will have to be made locally or through the Cancer Drugs Fund.

“It’s important that promising new drugs are made available to patients who need them and we look forward to the NICE decision on this drug which we hope will help improve survival for men with this disease.”
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 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.

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