GSK withdraws applications for Avodart
pharmafile | March 25, 2011 | News story | Research and Development | Avodart, Cancer, GSK, bph, prostate cancer
GlaxoSmithKline has withdrawn all regulatory applications for Avodart to prevent prostate cancer after regulators raised doubts about its benefit/risk profile.
Avodart (dutasteride), a 5-alpha reductase inhibitor, was under review in the US, Europe and other countries for reduction in the risk of low-grade prostate cancer in men at danger of developing the disease.
This decision to withdraw the drug is based on a recent complete response letter sent by the FDA’s oncologic drugs advisory committee that questioned the clinical significance of reducing the risk of low-grade prostate cancer.
The majority of men with low-grade, early prostate cancer (which means that cancer cells have been found only in the prostate gland) live a long time after their diagnosis as the disease grows very slowly.
Even without treatment, many of these men will not die of prostate cancer, but rather will live with it until they eventually die of some other unrelated cause, meaning a preventative drug may not be clinically significant.
The FDA committee also expressed uncertainties on the increased number of high-grade tumours in men treated with 5-alpha reductase inhibitors (5ARI) such as dutasteride, giving the drug a highly unfavourable risk/benefit ratio.
GSK said a combination of factors including the ongoing medical and scientific debate around the benefits and risks of 5ARIs for prostate cancer risk reduction, together with responses from regulators had caused it to withdraw ongoing applications for approval.
The company said it would work with regulatory agencies to remove this indication in countries where Avodart has already received a licence.
The submissions were based on findings from the 2009 phase III REDUCE trial that found dutasteride reduced the risk of all biopsy-detectable prostate cancer by 23% over four years.
Dutasteride is currently licenced in over 90 countries for the treatment of moderate-to-severe symptoms of benign prostatic hyperplasia (BPH) in men with an enlarged prostate.
GSK said it still believes that dutasteride for BPH continues to have a favourable risk/benefit profile but will continue working with regulatory agencies to update the existing labels for all dutasteride-containing medicines.
The update for physicians and patients will include relevant safety information from the REDUCE study and will continue to emphasise the importance of regular monitoring.
Ben Adams
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