HPV Vaccine Safe, Effective For Anal Cancer Prevention In Studies, FDA Document Says

Merck's human papillomavirus vaccine Gardasil is safe and effective at preventing anal cancer in both sexes, according to FDA background materials released on Monday, MedPage Today reports. The research materials were provided ahead of an FDA Vaccines and Related Biological Products Advisory Committee meeting on Wednesday.

The panel will discuss whether to expand Gardasil's approval to include prevention of anal cancer and associated precancerous lesions in people ages nine to 26. HPV is believed to cause 90% of anal cancers. Women have a higher incidence of anal cancer than men, though anal cancer rates are even higher among certain male populations, including men who have had receptive anal sex and those with HIV.

Gardasil was approved in 2006 to prevent genital warts and cervical cancer in girls and women ages nine to 26. The approval was expanded in 2009 to include prevention of male genital warts in the same age group. If the advisory committee agrees with information provided in the background document, it likely will endorse Merck's request for approval to prevent anal lesions and cancer. FDA is not required to follow the committee's recommendation, but it usually does.

Details of Background Materials

The FDA Center for Biologics Evaluation and Research analyzed new trial data on 4,065 men, including 602 men who have sex with men. Three percent of participants who received Gardasil developed anal cancer, compared with 12% in the placebo group. The vaccine was 78% effective at preventing anal intraepithelial neoplasia -- an abnormal cell growth associated with certain strains of HPV-- and 75% effective at preventing advanced dysplasia.

The reviewers concluded that the data show Gardasil is effective at preventing anal cancer caused by HPV in boys and men ages 16 through 25. The data can be extrapolated to women and younger people, they added. Merck did not submit new data on Gardasil's safety, but the reviewers said the vaccine "continues to have an acceptable safety profile" based on previous data provided to FDA (Walker, MedPage Today, 11/15).


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