FDA Advisory Panel Rejects Approval of Two Drugs for Prostate Cancer Prevention

An advisory panel to the Food and Drug Administration denied approval of dutasteride and finasteride, two drugs known as 5-alpha reductase inhibitors, for the prevention of prostate cancer.

Dutasteride and finasteride, along with other drugs of this class, work to reduce the effects of male hormones known as androgens.

The panel cited studies showing that the drugs did result in lowered incidence of low-grade prostate cancers, but also possibly resulted in a possible small increase in the risk of high-grade prostate cancers.