UK drug giant GlaxoSmithKline is pulling back applications around the globe seeking to market its benign prostatic hyperplasia (BPH) drug Avodart for preventing prostate cancer.
The move follows concern on both sides of the Atlantic that the benefit-risk equation is not in Avodart's (dutasteride) favour when used to cut in the risk of prostate cancer in men prone to the disease.
In January the US Food and Drug Administration issued a complete response letter following an advisory committee meeting that threw up questions over the clinical significance of cutting the risk of low grade prostate cancer, as well as uncertainties over whether Avodart (as well as Merck's rival Proscar) might boost the likelihood of more serious cancers.
According to GSK, it subsequently received similar feedback from regulators in Sweden, prompting its decision to withdraw applications for approval of the drug in this setting.
The company has not only pulled the plug on ongoing applications under regulatory review, but will also remove the prostate cancer indication in countries where approval has already been granted, it said.
Confident in BPH benefit
Avodart has been cleared for use in more than 90 countries to treat the symptoms of BPH in men with an enlarged prostate, as well as to reduce the risk of acute urinary retention and BPH-related surgery in some territories.
GSK stressed that it believes the drug continues to have a favourable benefit-risk profile for BPH, but noted that labels for all medicines containing dutasteride will be updated to highlight the importance of regular screening for PSA - an early marker for cancer.