Company will no longer seek approval for dutasteride (Avodart) to prevent prostate cancer


The pharmaceutical company GlaxoSmithKline said late Wednesday it would no longer seek approval to market its drug dutasteride (Avodart) for the prevention of prostate cancer. The company’s announcement comes after a Food and Drug Administration advisory panel in January voted against expanding the drug’s marketing approval to cover risk reduction for prostate cancer in high-risk men. Swedish authorities have also told the company they would not approve the new indication. The drug is approved for treating benign prostatic hyperplasia, a noncancerous enlargement of the prostate gland.

GlaxoSmithKline said it would withdraw applications for the new indication in all the countries where applications are currently pending. In countries where the application has been approved, the company said it would work with authorities to remove the indication from the product’s license.

In a major study published in April, researchers found that dutasteride reduced the incidence of prostate cancer by about a quarter in men who were at high risk of developing the disease. But critics charged that men who took the drug had a slightly higher risk of developing a more aggressive form of prostate cancer. Since then, there has been an ongoing debate over whether the drug actually contributed to the development of the more aggressive tumors or whether it simply allowed them to be detected earlier. The FDA advisory panel chose to err on the side of caution in refusing to recommend approval of the new indication for the drug, and GlaxoSmithKline is apparently following suit.