FDA Questions GSK on Avodart

FDA Questions GSK on Avodart
Drug Discovery & Development - January 28, 2011

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GlaxoSmithKline Plc. said the Food and Drug Administration is asking the company for more information before approving the drug Avodart for men at risk of getting prostate cancer.
The company did not provide details on the FDA request.
In December, a panel of experts recommended that the FDA deny approval to Avodart for the new use, citing safety concerns. Panelists voiced concern that a small number of men taking drugs actually developed more aggressive tumors.
In its review at the panel meeting, the FDA presented figures showing that for every 60 men treated with Avodart for four years, one serious case of prostate cancer would be prevented. But for every 200 men treated during the same timeframe, one would develop a high-grade tumor.
At the time, the head of the FDA's office of oncology drug products said the drug should be held to a higher standard because it would be used in healthy men, unlike traditional cancer treatments.
Avodart is already approved and sold as a treatment for enlarged prostate.
Date: January 27, 2011
Source: Associated Press