FDA Expands Gardasil Vaccine Indication to Include Anal Cancer

The Federal Drug Administration (FDA) announced yesterday their decision to expand the use of the human papillomavirus (HPV) vaccine, Gardasil, to prevent anal cancer and precancerous lesions. The HPV and Anal Cancer Foundation (the Foundation) testified in November before the FDA to urge the agency to approve Gardasil for the prevention of anal cancer in males and females.

“As advocates for the anal cancer community and members of a family that recently lost someone to the disease, we know how difficult treatment can be for a patient diagnosed with anal cancer,” said Justine Almada, co-founder of the Foundation. “We applaud the FDA for approving the anal cancer indication for Gardasil; this indication will help to prevent future families from experiencing the devastating effects of the disease. As HPV causes as much as 90% of anal cancer cases, the vaccine has the potential to significantly curb the number of anal cancer diagnoses. This is a great step towards eliminating anal cancer and other HPV-associated cancers for Americans.”

The HPV and Anal Cancer Foundation is a national public service organization dedicated to reducing the suffering of, and ensuring quality care for, those affected by anal cancer and HPV.

Justine, Tristan and Camille Almada, three siblings, founded the organization after the death of their mother, Paulette Crowther, from anal cancer in April 2010. During the two years from her diagnosis with stage IV anal cancer to her death, Ms. Crowther and her children were frustrated by low knowledge levels of preventative care measures and the limited options available to treat the disease. The chemotherapy and radiation treatments had harsh side effects on Ms. Crowther’s health and quality of life, and were ultimately unsuccessful, leading to her death at the age of 53.

Over 5,300 people are diagnosed with anal cancer every year in the United States and the incidence is increasing. HPV is the same virus that generates almost all types of cervical cancer, 90% of anal 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 approved the indication for the Gardasil vaccine for the prevention of anal cancer and associated precancerous lesions due to HPV types 6, 11, 16, and 18 in boys and girls ages 9 through 26 years. Gardasil was already approved by the FDA for the prevention of cervical, vulvar and vaginal cancer and pre-cancer in women, and genital warts in both genders.

In their announcement of the approval, the FDA recognized the positive effect vaccinating boys and girls will have: “treatment for anal cancer is challenging; 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,” said Karen Midthun, M.D., Director of the FDA’ s Center for Biologics Evaluation and Research.

On November 17, 2010, the Foundation testified before the FDA Advisory Committee on Vaccines and Related Biological Products to urge the decision on the Gardasil vaccine.

“For those who do have to fight anal cancer, we will continue to support research into more innovative and effective treatments. At the same time, we believe there is a great deal more that can be done to prevent people from having to experience the battle with anal cancer at all, including making HPV prevention more accessible to more populations, “ said Ms. Almada before the Committee. “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.”

The Foundation’s testimony 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 here.

 

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