Gardasil® Approved for Prevention of Vaginal and Vulvar Cancers

Gardasil® Approved for Prevention of Vaginal and Vulvar Cancers

The United States Food and Drug Administration (FDA) has expanded the indication for Gardasil® (Quadrivalent Human Papillomavirus [Types 6, 11, 16, 18] Recombinant Vaccine) for the prevention of cancers of the vagina and vulva.

Human papillomaviruses (HPV) consist of more than 100 different viruses. Some types of HPV cause warts on the hands or feet; others cause genital warts; and some have been linked with cancer, most notably cervical cancer. The types of HPV most commonly linked with cervical cancer are HPV 16 and HPV 18, but several other high-risk types contribute to cancer as well.

The types of HPV that cause cervical cancer or genital warts are transmitted sexually. HPV infection is extremely common and generally occurs soon after an individual becomes sexually active. Although most infections resolve on their own, some persist and can lead to precancerous or cancerous changes to the cervix, vulva, vagina, penis, and anus.

Gardasil is already approved for the prevention of cervical cancer caused by HPV types 16 and 18 for girls and women between the ages of 9 and 26 years. And although cancers of the vagina and vulva are rare, a significant portion of these cancers may also be caused by the human papillomavirus (HPV) types 16 and 18, allowing Gardasil to provide additional protection for these women.

The trial prompting the expanded indication for Gardasil included more than 15,000 young women who tested negative for HPV types 16 and 18 prior to the initiation of the trial. Approximately half of these participants received Gardasil, while the other half did not receive the vaccine. Cervical cancer was significantly reduced among women treated with Gardasil. As well, there were no precancerous areas of the vulva or vagina among women treated with Gardasil, while 10 individuals not treated with the vaccine developed precancerous areas of the vulva or vagina.

“There is now strong evidence showing that this vaccine can help prevent vulvar and vaginal cancers due to the same viruses for which it also helps protect against cervical cancer,” said Jesse L. Goodman, MD, MPH, director of the FDA’s Center for Biologics Evaluation and Research. “While vulvar and vaginal cancers are rare, the opportunity to help prevent them is potentially an important additional benefit from immunization against HPV.”

Reference: United States Food and Drug Administration. FDA Approves Expanded Uses for Gardasil to Include Preventing Certain Vulvar and Vaginal Cancers. Available at: Accessed September 2008.

Related News: Gardasil® Reduces Risk of Precancerous Changes to Vagina and Vulva (5/21/2007)