This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC's registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

31 Jan 2011

FDA Denies Cancer-prevention Use for GSK's Avodart

GSK received a complete response letter from the FDA rejecting Avodart as a way to reduce the risk of prostate cancer for now.

GlaxoSmithKline is not able to tout prostate drug Avodart as a cancer preventative, at least for now. FDA declined to approve the cancer-prevention indication for the drug, which is currently marketed to treat benign prostatic hyperplasia. Glaxo didn't offer any explanation of the FDA decision, and it didn't say whether it will pursue the application.


An approval would have allowed GSK to aim Avodart at the estimated 1 million men at higher risk of prostate cancer, which could have added up to $1 billion to its sales.

Related News