FDA approves Merck's Gardasil for prevention of anal cancer
WHITEHOUSE STATION, N.J. — Merck on Wednesday announced that the Food and Drug Administration has approved Gardasil [human papillomavirus quadrivalent (types 6, 11, 16 and 18) vaccine, recombinant] for the prevention of anal cancer in males and females 9 to 26 years of age.
According to the company, Gardasil is the first HPV vaccine on the market available for use in both men and women, 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% 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.
Anal cancer affects both men and women, with approximately 60% 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.