Merck's Gardasil, Approved For New Uses

Filed in archive Cancer , FDA Approvals , Treatment on September 15, 2008

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Photo courtesy of iStockphoto, Image# 5255912

The US FDA has recently approved additional uses for Merck's controversial HPV vaccine Gardasil: prevention of vaginal and vulvar cancer caused by Human Papillomavirus (HPV) types 16 and 18 in girls and women ages 9 to 26.

"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, M.D., M.P.H., 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."

The FDA originally approved Gardasil in 2006 for girls and women ages 9 to 26 for the prevention of cervical cancer caused by HPV types 16 and 18, precancerous genital lesions caused by HPV types 6, 11, 16, and 18 and genital warts caused by HPV types 6 and 11.

Read more from FDA News.