New prostate cancer drug discovered by ICR approved by FDA
18 May 2011
A drug for treating metastatic prostate cancer discovered at
The Institute of Cancer Research (ICR) has been approved by the US FDA.
The new drug, abiraterone acetate, has been approved for use in
combination with prednisone for the treatment of
“castration-resistant” prostate cancer in patients who have received
prior docetaxel chemotherapy.
“Today’s announcement marks the culmination of two decades of
work at the ICR to design and develop this drug,” ICR Chief
Executive Professor Alan Ashworth says. “This very significant
achievement underlines the importance of drug discovery work in the
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. Prostate cancer cells
need the male hormone testosterone to grow, so the team set out to
design a drug that would cut off the source of testosterone.
The ICR continued research on abiraterone acetate with the Royal
Marsden Hospital after the drug was licensed to Ortho Biotech
Oncology Research & Development, Unit of Cougar Biotechnology, Inc.
in 2004. ICR scientists worked with them on the pivotal trial that
led to the US approval. Cougar’s affiliate, Janssen Pharmaceutical
Companies, has a pending application for a license to sell the drug
Abiraterone blocks the CYP17 enzyme complex that is involved in
the synthesis of testosterone. Standard hormone treatments only
block production of male hormones in the testes and not the adrenal
glands, but recent research has shown that tumours can produce their
In addition, the adrenal gland continues to make male hormones.
By inhibiting the pathways involved in the production of
testosterone, abiraterone blocks its generation in all tissues,
including in the cancer itself. This means the drug has potential to
treat patients with the castration-resistant aggressive form of the
Prostate cancer is the most common male cancer in the UK, with
more than 35,000 new cases diagnosed annually. Around 10,000 men die
of the disease every year, almost all of them from its
Professor Johann de Bono from the ICR and The Royal Marsden
Hospital, who led the drug through Phase I, II and III clinical
trials, says: “Prostate cancer kills one man each hour in the UK.
New therapies are desperately needed. Abiraterone acetate has been
approved for men who are no longer responding to other drugs and so
we are very pleased that this decision means they will have another
treatment available to them.”