GSK resubmits data for approval of dutasteride to prevent prostate cancer

According to a media release earlier today, GlaxoSmithKline (GSK) has resubmitted data to the U.S. Food and Drug Administration (FDA) in support of the approval to market dutasteride (Avodart) as a drug to reduce the risk for prostate cancer among men believed to be at high risk.

GSK had initially submitted data to the FDA for this indication in 2009, but withdrew the original application because of a technical error in the submission.

It is believed that this submission is largely based on the data from the REDUCE trial that was reported in May 2009.

According to the media release from GSK, “The withdrawal of the initial application was not the result of new findings related to safety or efficacy. The update to the submission has not changed the interpretation of the data submitted.” Apparently the company also expects to resubmit a very similar application to the European Medical Agency in the near future

If dutasteride is approved for this indication (either in America or in Europe), it would be the first time that any therapeutic agent had been approved for the prevention of risk of prostate cancer. Both finasteride and dutasteride have been shown to reduce the risk of prostate cancer in about 25 percent of men in large clinical trials (copared to a placebo or sugar pill). The REDUCE trial, however, was focused exclusively on men believed to be at high risk for prostate cancer.

In late 2008, a clinical guideline issued jointly by the American Society for Clinical Oncology and the American Urological Association and published in the Journal of Urology in April 2009 has already recommended that:

Asymptomatic men with a prostate-specific antigen (PSA) ≤ 3.0 ng/ml who are regularly screened with PSA or are anticipating undergoing annual PSA screening for early detection of prostate cancer may benefit from a discussion of both the benefits of 5-ARIs for 7 years for the prevention of prostate  cancer and the potential risks (including the possibility of high-grade prostate cancer).

The “New” Prostate Cancer InfoLink has long argued that many men known to be at significant risk for prostate cancer should consider preventive medication using a 5α-reductase inhibitor like dutasteride or finasteride. Approval of dutasteride for such a clinical use would likely increase the probability that such men would become more aware of this option.

One Response

  1. As to the closing paragraph: AMEN … as well as other important reasons for the prescribing of the 5AR inhibitor dutasteride/Avodart.

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