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September 7, 2008 go to professionals site
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[ News >  CERVICAL CANCER ]

Cervical Cancer Vaccine Still Reserved for Younger Women

June Chen, MD

Cervical cancer is a malignant cancer of the cervix which is often asymptomatic, but is usually detected through routine Pap smear screening. Human papillomavirus (HPV) infection is associated with the development of cervical cancer, and an HPV vaccine effective against the two most common cancer-causing strains of the virus has been licensed in the United States for women aged 9 to 26. However, the U.S. Food and Drug Administration (FDA) recently announced that it has not yet approved an application for the use of an HPV vaccine called Gardasil® (marketed by Merck & Co.) in women between 27 and 45 years of age. The FDA has specific questions about the effectiveness of Gardasil® for older age groups, and Merck & Co. is expected to respond to these questions in July. It is also possible that the vaccine will be approved for use in men (to prevent them from spreading HPV to women) by the end of this year.

In other cervical cancer news - GlaxoSmithKline recently announced that its cervical cancer vaccine, Cervarix®, which is available in Europe, Mexico, Australia, and parts of Asia, will not be available in the United States till late 2009, at the earliest. The pharmaceutical company is expected to submit additional clinical trial data to the FDA for further review. So, despite the availability of an HPV vaccine, age limitations and approval delays mean that routine Pap smears are still the most important screening tool for cervical cancer.

Source
Reuters, June 25, 2008 and Financial Times, July 1, 2008.

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