FDA approves Gardasil for anal cancer prevention

FDA has approved Gardasil (Merck) for the prevention of anal cancer and associated precancerous lesions due to human papillomavirus (HPV) types 6, 11, 16, and 18 in individuals aged 9 through 26 years.

The vaccine’s ability to prevent anal cancer and the associated precancerous lesions [anal intraepithelial neoplasia (AIN) grades 1, 2, and 3] caused by anal HPV-16/18 infection was studied in a randomized, controlled trial of men who self-identified as having sex with men (MSM). The population was studied because it has the highest incidence of anal cancer. At the end of the study period, Gardasil was shown to be 78% effective in the prevention of HPV 16- and 18-related AIN. Because anal cancer is the same disease in males and females, the data was used to support the indication in females as well.

Gardasil will not prevent the development of anal precancerous lesions associated with HPV infections already present at the time of vaccination. For all the indications for use approved by FDA, Gardasil’s full potential for benefit is obtained by those who are vaccinated before becoming infected with the HPV strains contained in the vaccine.

Although anal cancer is uncommon in the general population, the incidence is increasing. HPV is associated with approximately 90% of anal cancer. The American Cancer Society estimates that about 5,300 people are diagnosed with anal cancer each year in the United States, with more women diagnosed than men.