Advisory Panel Discusses Expanded Indication for Avodart

Prior to an upcoming advisory panel meeting to discuss whether GlaxoSmithKline’s Avodart (dutasteride) should receive an expanded indication as a chemopreventive for prostate cancer, the FDA has released briefing documents noting that the 5-alpha reductase inhibitor increases the risk of high-risk prostate cancer. Whatever the panel decides might affect a request from Merck to change the label on Proscar (finasteride) to reflect study findings that it reduces the rate of low-risk prostate cancer.