Merck's Gardasil Approved to Prevent Anal Cancer

The US Food and Drug Administration has approved the vaccine Gardasil, manufactured by Merck and Co. Inc. (Whitehouse Station, NJ), for the prevention of anal cancer and associated precancerous lesions due to human papillomavirus (HPV) types 6, 11, 16, and 18 in people ages 9 through 26, according to an FDA press release.

Gardasil’s ability to prevent anal cancer and the associated precancerous lesions [anal intraepithelial neoplasia (AIN) grades 1, 2, and 3] caused by anal HPV-16/18 infection was studied in a randomized, controlled trial of men who self-identified as having sex with men. This population was studied because it has the highest incidence of anal cancer. At the end of the study period, Gardasil was shown to be 78% effective in the prevention of HPV 16- and 18-related AIN. Because anal cancer is the same disease in both males and females, the effectiveness data was used to support the indication in females as well.

Gardasil will not prevent the development of anal precancerous lesions associated with HPV infections already present at the time of vaccination. For all of the indications for use approved by the FDA, Gardasil's full potential for benefit is obtained by those who are vaccinated prior to becoming infected with the HPV strains contained in the vaccine.

In October 2009, the FDA approved Gardasil for the prevention of genital warts (condyloma acuminata) due to HPV types 6 and 11 in boys and men, ages 9 through 26.

In September 2008, Gardasil was approved for the prevention of vaginal and vulvar cancer caused by HPV types 16 and 18 in girls and women ages 9 to 26.

FDA’s press release