Merck announces FDA approval for GARDASIL against HPV-related anal cancer

Merck, known as MSD outside the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) has approved GARDASIL^® [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant] for the prevention of anal cancer caused by human papillomavirus (HPV) types 16 and 18 and for the prevention of anal intraepithelial neoplasia (AIN) grades 1, 2 and 3 (anal dysplasias and precancerous lesions) caused by HPV types 6, 11, 16 and 18, in males and females 9 through 26 years of age.

“GARDASIL is the only HPV vaccine available for use in both males and females, and the only one indicated to help prevent cervical, vaginal, vulvar and anal cancers and pre-cancers, as well as genital warts, caused by certain types of HPV.”

"We are pleased that with this new indication for GARDASIL against HPV-related anal cancer and disease, both males and females can be protected against cancer, which further reinforces the importance of vaccinating both genders," said Richard M. Haupt, M.D., MPH, executive director, Merck Research Laboratories. "GARDASIL is the only HPV vaccine available for use in both males and females, and the only one indicated to help prevent cervical, vaginal, vulvar and anal cancers and pre-cancers, as well as genital warts, caused by certain types of HPV."

In the United States, an estimated 75 to 80 percent of males and females will be infected with HPV in their lifetime. For most, HPV will clear on its own. However, for those who don't clear certain types, HPV can cause cervical, vaginal and vulvar cancers in women and anal cancer and genital warts in men and women. There is no way to predict who will or won't clear the virus.

GARDASIL helps protect against the four types of HPV, specifically types 6, 11, 16, and 18, that cause the most disease. It is estimated that HPV types 16 and 18 account for approximately 80 percent of anal cancers, 75 percent of cervical cancers, 70 percent of vaginal cancers and 40 to 50 percent of vulvar cancers. HPV types 6 and 11 cause approximately 90 percent of all genital warts cases.

Anal cancer affects both men and women, with approximately 60 percent of cases occurring in women. According to the American Cancer Society, it is estimated that approximately 2,000 men and more than 3,000 women will have been diagnosed with anal cancer in 2010. There is no standardized screening recommended for the general population for anal cancer and many people are diagnosed when the disease is more advanced.

GARDASIL^® [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant] was approved in the United States in 2006 and is also indicated for use in girls and young women 9 through 26 years of age for the prevention of cervical, vulvar and vaginal cancers caused by HPV types 16 and 18; genital warts (condylomata acuminata) caused by HPV types 6 and 11; and precancerous or dysplastic lesions caused by HPV types 6, 11, 16 and 18. GARDASIL is also approved in the U.S. for use in boys and men ages 9 through 26 years of age for the prevention of genital warts caused by HPV types 6 and 11.