J&J’s got some very good news when it learned that the FDA approved abiraterone acetate (Zytiga) for the treatment of men with metastatic castration-resistant prostate cancer who have received prior chemotherapy. The drug inhibits an enzyme that stimulates androgen production, offering a new approach to fighting the disease.
In clinical trials, those who received Zytiga and prednisone had a median overall survival of 14.8 months compared to 10.9 months for patients receiving the placebo and prednisone, according to a statement. The decision comes almost two months ahead of the June 20 deadline.
Wells Fargo analyst Larry Biegelson estimates annual sales of $800 million for the therapy by 2015. The treatment is likely to compete with Dendreon's Provenge, which costs $93,000 for a full course of treatment. The approval could also have implications for Medivation, which has been developing MDV-3100 for prostate cancer. See Xconomy and Fierce Biotech.
Posted by Bruce Lehr April 30th 2011.