National Cancer Institute NCI Cancer Bulletin: A Trusted Source for Cancer Research News
January 13, 2009 • Volume 6 / Number 1

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FDA Update

New Prostate Cancer Drug Approved

The FDA recently approved the injectable drug degarelix for the treatment of advanced, hormone-sensitive prostate cancer. Developed by Ferring Pharmaceuticals, degarelix prevents tumor growth by blocking signals from the pituitary gland that trigger the release of testosterone. A phase III study comparing it with a similar drug, leuprolide (Lupron Depot), showed that degarelix was just as effective at lowering testosterone levels, though it did so more quickly than leuprolide.

Gardasil Indication for Men Reviewed

The FDA is reviewing an application for approval of the Merck & Co. vaccine Gardasil for use in males. Data for the review come from a study of 4,000 boys and men aged 16 to 26, in which the vaccine reduced the risk of external genital lesions by 90 percent, according to a company press release. Gardasil targets the two types of human papillomavirus that are most commonly linked to cancer, including cancers of the cervix, vulva, vagina, anus, penis, and head and neck, and two other types linked to genital warts. It is currently approved for use in girls and women aged 9 to 26 years.

A Warning for Bone Density Drug

The January 1, 2009 issue of the New England Journal of Medicine includes a letter from Dr. Diane Wysowski of the FDA’s Division of Drug Risk Evaluation, citing reports of esophageal cancer and deaths in patients confirmed or suspected of taking the oral bisphosphonate alendronate (Fosamax) or other drugs in this class, which prevent bone weakness. In the United States, between 1995 and the middle of last year, 23 patients developed the disease and 8 died. In Europe and Japan, 31 patients developed esophageal cancer and 6 died. In some cases, these patients had Barrett esophagus, a known precursor to esophageal cancer.

“Esophagitis has been associated with oral bisphosphonates, usually when the drugs are not taken according to directions,” wrote Dr. Wysowski. She warned that physicians should not prescribe oral bisphosphonates to patients who have Barrett esophagus and that the drugs should be considered possible risk factors for esophageal cancer.