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FEATURE: Abiraterone receives approval from FDA to be marketed as a prostate cancer therapy - Zytiga

2011-07-28 00:00:00

On April 28th 2011, the US Food and Drug Adminstration (FDA) approved the use of abiraterone acetate, a new hormone therapy, in men with castration resistant prostate cancer. Definitive clinical trial results were subsequently published in the New England Journal of Medicine in May.  

Abiraterone was invented by Professor Mike Jarman and his colleagues in what is now the Cancer Research UK Cancer Therapeutics Unit at the Institute for Cancer Research (ICR), and facilitated by grants from Cancer Research UK in its former guise of the Cancer Research Campaign, the Medical Research Council (MRC) and BTG International LTD.

In 1993, a patent was filed for abiraterone, then known as CB7598, and it entered the Cancer Research Technology licensing portfolio. Cancer Research Technology later assigned abiraterone 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 phase I, II and III trials were all led by Professor Johann de Bono from the ICR and The Royal Marsden Hospital in collaboration with Cougar Biotechnology, Inc. which culminated in the recent FDA approval.

Zytiga™ is now available in the US as a once daily oral medication to be taken in combination with prednisone for the treatment of men with metastatic castration-resistant prostate cancer who have received prior chemotherapy containing docetaxel.

As of 22nd July, the European Committee for Medicinal Products for Human Use (CHMP) had referred abiraterone acetate to the European Commission for sign-off in what could be the final step before the drug can be accessed by men across Europe.

This new type of prostate cancer treatment would not have been possible without the combined and collaborative efforts of both academic researchers and industry sponsors and facilitators.

Zytiga™ represents CRT’s 4th drug that has progressed to market. Find out more about our clinical pipeline.

Notes to editors