Gardasil Gets FDA Nod for Prevention of Anal Cancer

Steven Fox

December 22, 2010

December 22, 2010 — There is a new indication for the recombinant human papillomavirus (HPV) vaccine Gardasil (Merck and Co): prevention of anal cancer by HPV types 6, 11, 16, and 18.

The US Food and Drug Administration (FDA) today approved use in patients aged 9 to 26 years, the agency said in a press release.

The vaccine already won approval for prevention of cervical, vulvar, and vaginal cancers, as well as for preventing precancerous lesions caused HPVs. It is also approved for prophylaxis against genital warts associated with HPVs 6 and 11 in both males and females.

Anal cancers are generally uncommon, but their incidence is increasing, especially among high-risk groups such as gay men. About 5300 new cases of anal cancer are diagnosed each year, and HPVs account for 9 of 10 cases.

In a randomized trial of gay men, the vaccine was found to be 78% effective in preventing HPV 16– and HPV 18–related anal cancers, according to the release.

Merck and Co, which manufactures the vaccine, says more than 65 million doses have been distributed since it was first approved in 2006.


Comments on Medscape are moderated and should be professional in tone and on topic. You must declare any conflicts of interest related to your comments and responses. Please see our Commenting Guide for further information. We reserve the right to remove posts at our sole discretion.