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news.Merck & Co. has applied to expand the labeling of its cervical cancer vaccine Gardasil to also include vaginal and vulvar cancers.
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Gardasil is cleared as a vaccine against four strains of the human papillomavirus, or HPV.
The new submission for Gardasil includes efficacy data showing some protection against additional cervical cancer causing HPV types and also data on protection against vaginal and vulva cancer.
Within 60 days following submission, the FDA will determine whether it will accept for review Merck's application as submitted.
“Merck is pleased to also file for indications to help protect against two additional gynecological cancers to further extend the value that Gardasil offers to females,” said Beverly Lybrand, vice president, HPV Franchise, Gardasil, Merck Vaccines.
According to Merck, Gardasil has been approved in more than 60 countries including the US, the 27 countries of the European Union, Mexico, Australia, Taiwan, Canada, New Zealand and Brazil.