The US Food and Drug Administration (FDA) has approved a new indication for Gardasil—the prevention of anal cancer and associated precancerous lesions caused by the human papillomavirus (HPV) types 6, 11, 16, an 18 in patients 9 to 26 years of age.
The vaccine is already approved for the prevention of cervical, vulvar, and vaginal cancer in this female cohort of this population, as well as the prevention of genital warts in men and women.
Approval was based on a randomized, controlled trial of men who have sex with men, a population with high incidence of anal cancer. Gardasil was 78% effective in the prevention of anal cancer related to HPV 16 and 18. Because the disease is the same in both sexes, approval was granted for prevention in men and women.
Read the FDA release: