The Anal Cancer Foundation Calls on FDA to Approve HPV Vaccine Gardasil to Prevent Anal Cancer in Men and Women

The Anal Cancer Foundation (the "Foundation") testified November 17, 2010 before the Federal Drug Administration (FDA) Advisory Committee on Vaccines and Related Biological Products to urge the agency to approve the human papillomavirus (HPV) vaccine, Gardasil, for the prevention of anal cancer in men and women. Gardasil is currently approved by the FDA for the prevention of cervical, vulvar and vaginal cancer and pre-cancer in women, and genital warts in both genders.

"The approval of the anal cancer indication for the HPV vaccine will offer a new method to prevent a painful diagnosis and death from a disease in which significant progress in treatment has stagnated for decades," said Foundation co-founder Justine Almada during the public comment period. "We strongly urge [the FDA] today to approve expanding the Gardasil indication to include prevention of anal dysplasia and anal cancer in both females and males.”

Over 5,200 people are diagnosed with anal cancer every year in the U.S. alone. As much as 90% of anal cancers are caused by HPV, the same virus that generates almost all types of cervical cancer, and many types of vulvar, vaginal, penile, skin, and head and neck cancers. 75% of sexually active persons will be infected by HPV at least once in their lifetime. HPV will cause 25,000 cancers in the U.S. this year.

The FDA is considering a Merck Biologics License Application supplement for Gardasil with respect to anal cancer and associated precancerous lesions called anal intraepithelial neoplasia ("AIN") in both males and females. The application under consideration shows that the Gardasil vaccine results in a 78% reduction in early stage anal pre-cancer caused by HPV types 6, 11, 16 and 18, in a cohort study of healthy men-who-have-sex-with-men. On more advanced anal pre-cancer (AIN II & AIN III), the vaccine efficacy falls slightly to 75%.

The FDA advisory panel supported the vaccine’s expanded use in preventing anal cancer and AIN in both men and women. A final decision on the vaccine’s expanded indication is expected from the FDA by the end of the year. There were only minor revisions to the safety data originally submitted for the pivotal efficacy study in males, when the FDA approved the vaccine’s indication for genital warts in 2006. No new serious adverse events, deaths, or new subject discontinuations due to adverse experiences were reported.

The Foundation’s testimony also highlighted:

• The increasing incidence of anal cancer in the U.S. population and the lack of new therapeutics to treat these patients.

• The physical burden of treating anal cancer and precancerous lesions, which can include chemotherapy, radiation, and life-changing surgery such as ostomies.

• The social stigma surrounding anal cancer that prevents equitable focus on and funding for the disease.

• The need to increase accessibility to preventative medicine across the population for HPV-related diseases, such as the HPV vaccine.

• The need to protect both men and women from anal cancer by making the vaccine available to both sexes.

• The importance of making the vaccine available to boys as they may not identify their sexual orientation until sexual activity has commenced.

• The similar natural history of HPV infection in men and women, which illustrates the vaccine would be effective in preventing anal cancer and precancer also in women.

Read the Foundation's full testimony.