2:27pm

Thu January 27, 2011
Shots - Health News Blog

Avodart Gets Rejected By FDA For Reducing Prostate Cancer Risk

Even as snow socked Washington, the Food and Drug Administration managed to get a letter to GlaxoSmithKline rejecting the company's proposal to sell the pill Avodart as a way to reduce the risk of prostate cancer.

The medicine, known generically as dutasteride, is prescribed to ease the symptoms and reduce the need to operate on enlarged prostates. Glaxo has been looking to get the drug approved for the prevention of prostate cancer in men with high PSAs and who've had a biopsy for prostate cancer that didn't find any.

Back in December, a panel of experts advising the FDA about the proposal voted it down 14-2 because the benefit of reducing some cancers didn't outweigh the risks that some aggressive cancers would go unnoticed.

FDA said at the meeting that the company's data showed 60 men would need to be treated with Avodart for four years to prevent a single "clinically meaningful" case of prostate cancer, the Wall Street Journal reported at the time. Among the same men over the same period, about 1 in 200 treated with Avodart would develop an aggressive type of prostate cancer.

In an e-mail, a Glaxo spokesman said the company is still reviewing the letter, which it received around 7 p.m. Wednesday. (That's when parts of suburban Washington near FDA headquarters were hit with thundersnow.) Glaxo expects to talk it over with the agency, but the company hasn't made a decision about whether to continue work on approval. Copyright 2011 National Public Radio. To see more, visit http://www.npr.org/.