Human papillomavirus (HPV) quadrivalent (types 6, 11, 16, and 18) vaccine, recombinant (Gardasil; Merck), was recommended for an expanded indication — prevention of anal cancer in males and females ages 9 through 26 years — at a US Food and Drug Administration (FDA) advisory panel meeting yesterday.
The FDA's Vaccines and Related Biological Products Advisory Committee mulled over the recent data to consider the expanded indication.
Panelists were asked to comment on 2 discussion topics: the strength of the data to support an indication for the prevention of anal intraepithelial neoplasia (AIN) and anal cancer in males and the scientific rationale for extrapolating efficacy in the prevention of AIN and anal cancer to females.
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