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FDA panel votes against GSK cancer drug

Advisors to the US FDA have recommended against approval of GSK's Avodart (dutasteride) for the additional indication of reduction of the risk of prostate cancer in high-risk populations
Advisors to the US Food and Drug Administration (FDA) voted on Wednesday to recommend against approval of GlaxoSmithKline's (GSK) marketed benign prostatic hyperplasia (BPH) drug Avodart (dutasteride) for the additional indication of reduction of the risk of prostate cancer in high-risk populations.

GSK is seeking approval of the risk-reduction indication for men who have had a prior negative biopsy due to clinical concern and have an elevated serum prostate-specific antigen level. 

After discussion of GSK's supplemental New Drug Application (sNDA), the Oncologic Drugs Advisory Committee voted 14-2 against the proposition that dutasteride's risk/benefit profile is favourable for reduction in the risk of prostate cancer in the target population. There were two abstentions. 

The outside advisors' conclusions were in line with those of internal FDA reviewers who prepared briefing documents that were made available in advance of the meeting. The FDA staff reviewers pointed out that although a four-year study showed that at-risk men taking the drug were 23 per cent less likely to develop prostate cancer, more men on the drug than on placebo developed aggressive tumours.

The advisors also voted against Merck's request that it be allowed to add data supporting prostate-cancer risk reduction to the label of its marketed BPH therapy Proscar (finasteride). Merck did not submit an sNDA seeking approval for a new indication, but the advisors voted 17-0 with one abstention that the FDA should reject the company's label change request. 

The FDA is not required to follow the recommendations of its panels of outside advisors, but it frequently does so. 

GSK said that it would continue to work with the FDA on the review of its NDA, and stressed Avodart's “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.” 

Avodart was approved in late 2002 for the BPH indication to improve urinary symptoms, reduce risk of acute urinary retention and reduce the risk of the need for BPH-related surgery. The drug was launched in the US in 2003 and had global sales of about $830m last year. Some financial analysts had originally predicted that a prostate cancer risk reduction indication could more than double those sales, but the safety concerns may make that less likely even if the sNDA is eventually approved. 

2nd December 2010

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