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ODAC rebuffs Proscar, Avodart for prostate cancer

December 2, 2010 1:27 AM UTC

FDA's Oncologic Drugs Advisory Committee voted Wednesday against recommending approval of two benign prostatic hyperplasia (BPH) drugs for prostate cancer: Proscar finasteride from Merck & Co. Inc. (NYSE:MRK) and Avodart dutasteride from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK). The committee voted 17-0, with one abstention, that the benefit-risk profile of Proscar did not support approval for the reduction in the risk of prostate cancer in men at least 55 years of age with a normal digital examination and a PSA of at most 3 ng/mL. Merck is not seeking approval of Proscar for prostate cancer; however, it is seeking to include data on Proscar's label from the Prostate Cancer Prevention Trial (PCPT) suggesting the drug reduces risk of the disease. The 5-alpha reductase inhibitor is already approved to treat symptomatic benign prostatic hyperplasia (BPH). ...