NEW YORK (AP) – The Food and Drug Administration has approved Johnson & Johnson’s new pill Zytiga as a treatment for men with prostate cancer who have already undergone chemotherapy.
Testosterone stimulates the growth of prostate tumors, and treatment can include drugs or surgery aimed at cutting the body’s testosterone production. However some prostate tumors continue to grow even after those treatments. Zytiga, or abiraterone, is designed to target a protein that plays an important role in making testosterone, thereby reducing the hormone’s production.
J&J said a trial of nearly 1,200 patients showed that those treated with Zytiga once-daily in combination with the steroid prednisone lived an average of four months longer than those treated with prednisone and a placebo.
The FDA said Thursday that it approved the drug for use by patients who were already treated with the cancer drug Taxotere, an injectable chemotherapy drug made by Sanofi-Aventis SA. The clearance comes well ahead of the agency’s scheduled decision date of June 20.
Zytiga was developed by Cougar Biotechnology Inc., a company that New Brunswick, N.J.-based Johnson & Johnson acquired in July 2009 for $893.7 million. Cougar became part of Johnson & Johnson’s Centocor Ortho Biotech unit.
Date: April 29, 2011
Source: Associated Press