5-ARI manufacturer will not seek prostate Ca prevention indication

GlaxoSmithKline has announced that it will no longer pursue global approval for the use of the 5-alpha-reductase inhibitor dutasteride (Avodart) to reduce the risk of prostate cancer.

In a statement, the company said it would withdraw applications from regulatory review where procedures are ongoing and, in the limited number of countries where dutasteride is already indicated for use in prostate cancer risk reduction, it will work with regulatory agencies to remove this indication from the product’s license and support physicians to communicate appropriately to patients.

The prostate cancer risk reduction applications were based on findings from the phase III REDUCE (Reduction by Dutasteride of Prostate Cancer Events) trial, which found that the drug, currently indicated for treatment of BPH, reduced the risk of biopsy-detectable prostate cancer by about one-fourth in men at high risk for the disease.

In January 2011, GSK received a complete response letter following an FDA Oncologic Drugs Advisory Committee Meeting in December 2010, when the majority voted against a favorable risk/benefit profile for dutasteride for reduction in the risk of prostate cancer in men at risk for the disease. This was essentially due to questions regarding the clinical significance of reducing the risk of low-grade prostate cancer and uncertainties surrounding the possible explanations for the increased number of cases of high-grade tumors in men treated with 5-alpha-reductase inhibitors for prostate cancer risk reduction.

The company added that a combination of factors, including the ongoing medical and scientific debate around the benefits and risks of 5-alpha-reductase inhibitors for prostate cancer risk reduction, together with feedback from regulatory agencies, caused it to carefully consider its approach to the indication and subsequently withdraw ongoing applications for approval.