FDA rejects new use for GSK's Avodart

The US Food and Drug Administration (FDA) has declined to approve a supplemental new drug application submitted by GSK seeking a new indication for Avodart (dutasteride) for reducing the risk of prostate cancer in men who are at increased risk for the disease.

Avodart is already approved for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to improve symptoms, reduce the risk of acute urinary retention, and reduce the risk of the need for BPH-related surgery. In addition, it is cleared for use in combination with the alpha-blocker tamsulosin for the treatment of symptomatic BPH in men with an enlarged prostate.

GSK's latest application had been seeking FDA's permission to market the drug to reduce prostate cancer risk in men who have had a prior negative biopsy due to clinical concern and have an elevated serum prostate-specific antigen. The company did not indicate whether it would continue to pursue the new indication in light of the complete response letter.

In December, the FDA's Oncologic Drugs Advisory Committee voted 14 to 2 to recommend against approval of the new indication. The advisors 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.

Avodart 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.