FDA Advisory Committee Backs Second Cervical Cancer Vaccine

Posted on September 11th, 2009 by

A U.S. Food and Drug Administration (FDA) advisory committee has concluded that Cervarix®—a vaccine against two high-risk types of human papillomavirus (HPV)—is safe and effective for the prevention of cervical cancer.

Human papillomaviruses 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 HPV16 and HPV18, 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. HPV infection has also been linked to certain cancers of the head and neck.

Recognition of the link between HPV and cervical cancer led to the development of vaccines designed to prevent infection with certain high-risk types of HPV. Gardasil® targets HPV types 6 and 11 (which are linked with genital warts) as well as the cancer-associated types 16 and 18. Gardasil was approved by the FDA in June 2006. Cervarix targets HPV types 16 and 18 only. Cervarix has not yet been approved in the United States but has been approved in many other countries. A potential advantage of Cervarix is that it uses a new type of adjuvant (a substance added to increase immune response); this may boost the strength or duration of vaccine protection.

In its review of Cervarix, the advisory committee voted 11 to 1 in favor of safety and 12 to 1 in favor of effectiveness. The FDA is not obligated to follow the recommendations of its advisory committees but often does.

Reference: GlaxoSmithKline press release. FDA advisory committee makes favorable recommendation for Cervarix, GlaxoSmithKline’s candidate cervical cancer vaccine. Available at: http://www.gsk.com/media/pressreleases/2009/2009_us_pressrelease_10056.htm. Accessed September 10, 2009.

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