FDA approves Gardasil to prevent anal cancer

January 5, 2011

The Food and Drug Administration (FDA) has approved Gardasil (human papillomavirus [HPV] quadrivalent vaccine, recombinant; Merck) for the prevention of anal cancer and associated precancerous lesions due to HPV types 6, 11, 16 and 18 in people ages 9 through 26 years, PRNewswire-USNewswire reports.

Silver Spring, Md. - The Food and Drug Administration (FDA) has approved Gardasil (human papillomavirus [HPV] quadrivalent vaccine, recombinant; Merck) for the prevention of anal cancer and associated precancerous lesions due to HPV types 6, 11, 16 and 18 in people ages 9 through 26 years, PRNewswire-USNewswire reports.

Gardasil previously was approved for the same age group for the prevention of cervical, vulvar and vaginal cancer and the associated precancerous lesions caused by HPV types 6, 11, 16 and 18 in females. It also is approved for the prevention of genital warts caused by types 6 and 11 in both males and females.

The vaccine’s ability to prevent anal cancer and associated precancerous lesions was studied in a randomized, controlled trial of men who self-identified as having sex with men - the population that has the highest incidence of anal cancer. The study showed Gardasil to be 78 percent effective in the prevention of HPV 16- and 18-related anal intraepithelial neoplasia (AIN).

PRNewswire-USNewswire quotes Karen Midthun, M.D., director of the FDA’s Center for Biologics Evaluation and Research, as saying, “The use of Gardasil as a method of prevention is important, as it may result in fewer diagnoses and the subsequent surgery, radiation or chemotherapy that individuals need to endure.”