GSK Gets Complete Response on Avodart for Prostate Cancer Risk Reduction

GlaxoSmithKline (GSK) has received a complete response letter on its Avodart sNDA for reducing the risk of prostate cancer in men at increased risk for the disease. The letter comes after an FDA advisory committee last month voted against recommending approval for Avodart (dutasteride) and Merck’s Proscar (finasteride) as preventive treatments for prostate cancer. Several of the panel members expressed concern about a finding in clinical trials of both drugs that showed while they were effective in reducing the risk of patients developing low-grade tumors, there was actually an increase in more serious, high-grade tumors in patients taking the drugs.
Drug Industry Daily