Gardasil Gets FDA OK For Anal Cancer


The vaccine Gardasil can now add anal cancer to the list of cancers for which it has FDA (Food and Drug Administration) approval. Merck & Co. Inc’s vaccine had prior approval for the prevention of cervical, vulvar, and vaginal cancer caused by human papillomavirus (HPV) in females ages 9 to 26.

Anal cancer is a rare but deadly disease

According to a report in the Wall Street Journal, the FDA noted that HPV is associated with approximately 90 percent of cases of anal cancer. This form of cancer, which claimed the life of Farrah Fawcett in 2009, forms in the tissues of the anus.

The National Cancer Institute estimates that 5,260 new cases of anal cancer (2,000 men, 3,260 women) will be diagnosed in 2010, and 720 people will die of the disease. The vast majority of cases occur in people age 45 years and older, with 60 being the average age at diagnosis.


HPV is the most common sexually transmitted infection, yet most people who become infected do not know they have it. More than 40 different types of HPV are known, and they can infect the genital areas, mouth, and throat of both males and females.

Gardasil is the only HPV vaccine that helps protect against 4 types of HPV. According to the Merck website, in females ages 9 to 26, Gardasil helps protect against 2 types of HPV that cause about 75 percent of cervical cancer cases and 2 more types that cause 90 percent of genital warts. It also protects females against 70 percent of vaginal cancer and up to 50 percent of vulvar cancer cases. In males 9 to 26 years, Gardasil helps protect against 90 percent of genital warts cases.

The FDA approval of Gardasil for anal cancer had the backing of an FDA advisory panel, which last month said there was sufficient evidence to go ahead.

Merck & Co. Inc.
National Cancer Society
Wall Street Journal