FDA approves J&J's prostate cancer drug Zytiga

Johnson & Johnson's billion-dollar buyout of Cougar Biotech has paid off. The FDA has approved Zytiga (abiraterone acetate) in combination with prednisone for patients with late-stage castration-resistant prostate cancer who have previously received chemotherapy. 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.

Zytiga, an oral drug, targets a protein called cytochrome P450 17A1 (CYP17A1). The protein plays a key role in the production of testosterone, which in turn stimulates cancer cell growth. Currently, physicians use surgery or drugs to block testosterone. Now patients who resist such approaches will have Zytiga as a last measure of defense. A spokesperson for Johnson & Johnson told FierceBiotech that the drug will cost $5,000 for a month's supply, $40,000 for an eight-month course of treatment.

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.

"Zytiga prolonged the lives of men with late-stage prostate cancer who had received prior treatments and had few available therapeutic options," said Richard Pazdur, director of the FDA's Office of Oncology Drug Products in a statement.

J&J inked a $1 billion deal for Cougar in 2009. The small company was developing breast cancer and multiple myeloma drugs in addition to its treatment for prostate cancer.

- here's the release on Zytiga
- here's the Bloomberg story