FDA denies cancer-prevention use for GSK's Avodart

GlaxoSmithKline won't get the chance to tout prostate drug Avodart as a cancer preventative, at least not yet. FDA declined to approve the cancer-prevention indication for the drug, which is currently marketed to treat benign prostatic hyperplasia. 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.

The decision comes after an FDA advisory panel recommended against the new indication, based on questions about potential risks. Clinical data had shown that the drug did help stave off lower-risk tumor types, but also suggested a possible increased risk of aggressive tumors. The panel voted 14-2 to recommend against it, saying that risk outweighed the benefits.

We don't know, of course, what the FDA's complete response letter says. Glaxo didn't offer any explanation of the FDA decision, and it didn't say whether it will pursue the application.

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