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Home Other HPV Cancers Other HPV Cancers Gardasil Approved to Prevent Anal Cancer

Gardasil Approved to Prevent Anal Cancer

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In late December the Food and Drug Administration (FDA) expanded the indication for Merck's HPV vaccine Gardasil® for use in preventing anal precancer (known as anal intraepithelial neoplasia, or AIN) and cancer in men and women ages 9-26. FDA’s vaccine advisory subcommittee had recommended in November that the anal cancer indication be approved.

Gardasil® is currently approved for the prevention of genital warts and cervical, vaginal, and vulvar precancers and cancers in females ages 9-26. The vaccine is also licensed to prevent genital warts in males in the same age range.

The move to approve Gardasil® for anal cancer prevention was based largely on research with men who have sex with men (MSM) that found the vaccine was 77.5 % effective in preventing AIN related to the HPV types covered by the vaccine.

The new indication covers both genders despite the Merck data focusing on men. The company says this is not an issue because the disease is similar in both males and females.

Anal cancer is fairly uncommon (the American Cancer Society estimates about 5,300 new cases occur in the U.S. each year), but the CDC says the risk of the disease in gay and bisexual men is 17 times greater than heterosexual men. About 60% of anal cancers are diagnosed in females.

The FDA decision means the Advisory Committee on Immunization Practices’ (ACIP) HPV Vaccine Workgroup will then have much to mull over when considering potential recommendations for an anal cancer indication, including whether or not to endorse routine use of the vaccine with boys and young men. ACIP provides guidance to the Secretary of the Health and Human Services (HHS) and the Centers for Disease Control and Prevention (CDC) about the appropriate use of vaccines – including those for HPV - in the civilian population. The Committee’s next meeting is scheduled for February 2011.

Current ACIP recommendations with Gardasil® are for routine use with females ages 11-12, with catch-up vaccination for females ages 13-26 who haven’t been immunized. ACIP also supports use of Gardasil® at health care provider’s discretion with males ages 9-26.