FDA advisory committee votes against Avodart sNDA for prostate cancer risk reduction

GlaxoSmithKline (NYSE: GSK) today announced the results of a U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) meeting to discuss the supplemental New Drug Application (sNDA) for Avodart® (dutasteride) for reducing the risk of prostate cancer in men at risk for the disease, defined as those who have had a prior negative biopsy due to clinical concern and have an elevated serum prostate-specific antigen (PSA). When asked if the dutasteride risk/benefit profile is favorable for reduction in the risk of prostate cancer in this target population, the ODAC voted 14 against, 2 in favor, and 2 abstentions.

"While we are disappointed by the Committee's conclusions on dutasteride as a prostate-cancer risk-reduction therapy, it is important to note that dutasteride has an established efficacy and safety profile in the treatment of BPH, including trials involving 10,000 men and the cumulative of 5.5 million years of patient exposure," said Anne Phillips, MD, vice president, medicine development leader, Oncology Research and Development, GlaxoSmithKline. "We will continue to work with the FDA on the review of the sNDA."