A US Food and Drug Administration panel yesterday voted against the use of GlaxoSmithKline's dutasteride (Avodart) and Merck's finasteride (Proscar) to reduce the risk of prostate cancer in men. The Oncology Drugs Advisory Committee had discussed supplemental New Drug Applications (sNDAs) for Avodart and Proscar.

In a press release, GlaxoSmithKline expressed their disappointment: "Whilst 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 Dr Anne Phillips, vice president, medicine development leader, Oncology Research and Development, GlaxoSmithKline. "We will continue to work with the FDA on the review of the sNDA."

Source: GlaxoSmithKline