FDA approves Gardasil for prevention of anal cancer

The US Food and Drug Administration (FDA) has approved use of the vaccine Gardasil in the population ages 9 through 26 years for the prevention of anal cancer and anal intraepithelial neoplasia (AIN) precancerous lesions grades 1, 2, and 3 caused by human papillomavirus (HPV) types 6, 11, 16, and 18.

Gardasil already is approved for the prevention of cervical, vulvar, and vaginal cancer and associated precancerous lesions caused by HPV types 6, 11, 16, and 18 in females, and for the prevention of genital warts caused by types 6 and 11 in both males and females.

In a randomized, controlled trial of men who had acknowledged having sex with men, the population with the highest incidence of anal cancer, Gardasil was 78% effective in the prevention of HPV 16- and 18-related AIN. Because anal cancer is the same disease in both men and women, the data supports the indication for females as well.

According to the FDA, persons who receive Gardasil before becoming infected with the HPV strains contained in the vaccine will achieve full protection for all FDA-approved indications for use. The vaccine will not prevent the development of AIN associated with HPV infections already present at the time of vaccination. Most common adverse events reported include fainting, pain at the injection site, headache, nausea, and fever.

HPV is associated with nearly 90% of anal cancer, and although anal cancer is not common in the general population, its incidence is increasing. The American Cancer Society estimates that about 5,300 new cases of anal cancer are diagnosed in the United States each year, with more women being diagnosed than men.