FDA Approves Gardasil for Prevention of Anal Cancer

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Anal cancers are generally uncommon, but the incidence is increasing, especially among high-risk groups such as gay men.  In the US, about 5,300 new cases of anal cancer are diagnosed each year, and HPVs account for 90% of the cases. 

On December 22, 2010, FDA approved Gardasil, the recombinant HPV (human papillomavirus quadrivalent (Types 6, 11, 16 and 18) vaccine made by Merck & Co., for the prevention of anal cancer caused by HPV types 6, 11, 16, and 18 in patients aged 9 to 26 years. 

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

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

Source: FDA press release, 2010 

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