Abiraterone

Abiraterone is a drug used in castration-resistant prostate cancer (formerly hormone-resistant or hormone-refractory prostate cancer) -- i.e., prostate cancer not responding to androgen deprivation or treatment with antiandrogens. It is formulated as the prodrug abiraterone acetate and marketed under the trade name Zytiga.

After an expedited six-month review, abiraterone was approved by the U.S. Food and Drug Administration (FDA) in April 2011. In Phase III trials, it extended median survival to 14.8 months versus 10.9 months placebo, and the trial was stopped because of the successful outcome.

In the UK, despite being licensed by the European Medicines Agency, the drug is not currently available for routine use on the NHS. In February 2012, the National Institute for Health and Clinical Excellence (NICE) issued preliminary guidance that the drug will not be made available on cost-effectiveness grounds, but this decision is open to consultation. The decision was reversed in May 2012.