FDA approves abiraterone for advanced prostate cancer

Men with metastatic prostate cancer that no longer responds to hormone therapy now have yet another treatment option: abiraterone (Zytiga). The FDA approved the drug, which is used in combination with a low-dose steroid, at the end of April 2011.

Approval was granted based on findings of a large, multicenter phase III clinical trial that were announced last fall. Participants who were treated with both abiraterone and the steroid prednisone lived, on average, almost four months longer than those treated with the steroid alone (14.8 months compared with 10.9 months). The trial involved 1,195 men from 13 countries with castration-resistant prostate cancer, which means that traditional hormone therapy is no longer keeping the disease in check. Prior to the trial, patients had also received docetaxel (Taxotere), a type of chemotherapy.

The most commonly reported side effects of abiraterone included joint swelling or discomfort, low levels of potassium in the blood, fluid retention in the legs and feet, increases in blood pressure, muscle aches, hot flashes, and urinary and gastrointestinal problems.

Abiraterone is the third drug to be approved for men with late-stage prostate cancer in the last year. In April 2010, the FDA approved sipuleucel-T (Provenge), a vaccine that uses the immune system to fight advanced-stage disease. Two months later, the agency gave the green light to the chemotherapy drug cabazitaxel (Jevtana). Prior to that, patients had few options.

Bloomberg business news reported that abiraterone’s manufacturer, Johnson & Johnson, is likely to sell the drug for an average wholesale price of $5,000 a month, with treatment typically lasting about eight months.

For more information, read the FDA’s press release.

Published May 2, 2011.