A drug discovered at the UK’s Institute of Cancer Research has been approved in the US for use by men with metastatic prostate cancer.
After priority review, the US Food and Drug Administration has approved the use of Johnson & Johnson’s Zytiga (abiraterone acetate) as an oral, once-daily medication for use in combination with prednisone for the treatment of men with metastatic castration-resistant prostate cancer who have received prior chemotherapy containing docetaxel.
The approval “marks the culmination of two decades of work at the ICR to design and develop this drug,” said Professor Alan Ashworth, chief executive of the ICR, which is Europe’s leading cancer research centre. “This very significant achievement underlines the importance of drug discovery work in the not-for-profit sector,” he added.
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, and the Institute continued research on the drug with the Royal Marsden Hospital after it was licensed to Cougar Biotechnology, in 2004. Cougar was subsequently acquired by J&J, whose Janssen affiliate has a pending application for a licence to sell the drug in Europe; it is not currently available in the UK.
“In a Phase III study, treatment with Zytiga plus prednisone showed a significant increase in median survival compared with placebo plus prednisone,” said Johann de Bono from the ICR and The Royal Marsden NHS Foundation Trust, who led the drug through Phase I, II and II clinical trials.
“Prostate cancer kills one man each hour in the UK. New therapies are desperately needed,” Prof de Bono added.
Following the US approval, UK specialist health care company BTG will receive an undisclosed milestone payment together with a royalty on worldwide sales of the drug. The firm’s chief executive officer, Louise Makin, said abiraterone acetate “provides a new treatment option for men with advanced metastatic prostate cancer.”
