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FDA advisors support anal cancer vaccine

Outside advisors to the US Food and Drug Administration have recommended the approval of Merck's Gardasil in preventing anal cancer

A panel of outside advisors to the US Food and Drug Administration (FDA) have recommended that the agency approve Merck's marketed cervical cancer vaccine Gardasil for the new indication of preventing anal cancer, which is caused by human papillomavirus (HPV) in approximately 90 per cent of cases. 

The Vaccines and Related Biological Products Advisory Committee voted that the data supplied by Merck support the safety and efficacy of Gardasil (human papillomavirus quadrivalent Types 6, 11, 16, and 18 vaccine, recombinant) for the prevention of anal cancer and anal intraepithelial neoplasia in men and women between nine and 26 years of age.

The HPV vaccine is already approved in the US  for female patients between the ages of nine and 26 to prevent cervical, vulvar and vaginal cancers, as well as genital warts and precancerous or dysplastic lesions.

Merck filed a supplemental Biologics Licence Application seeking approval for the anal cancer indication early this year.  Although the FDA is not required to follow its advisory committees' advice in evaluating marketing applications, it frequently does so.

Merck's supplementary application was based on the results of a study of men who have sex with men because of the high risk of anal infection in the population. However, the company is seeking approval in both men and women based on the research because the disease is similar in both sexes.

19th November 2010

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