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Gardasil HPV Vaccine Approved by the FDA for Anal Cancer Prevention
 
 
  "HPV is the most common sexually transmitted infection, yet most people who become infected do not know they have it. More than 40 different types of HPV are known, and they can infect the genital areas, mouth, and throat of both males and females......
 
The National Cancer Institute estimates that 5,260 new cases of anal cancer (2,000 men, 3,260 women) will be diagnosed in 2010, and 720 people will die of the disease. The vast majority of cases occur in people age 45 years and older, with 60 being the average age at diagnosis.
 
Gardasil is the only HPV vaccine that helps protect against 4 types of HPV. According to the Merck website, in females ages 9 to 26, Gardasil helps protect against 2 types of HPV that cause about 75 percent of cervical cancer cases and 2 more types that cause 90 percent of genital warts. It also protects females against 70 percent of vaginal cancer and up to 50 percent of vulvar cancer cases. In males 9 to 26 years, Gardasil helps protect against 90 percent of genital warts cases.
 
The FDA approval of Gardasil for anal cancer had the backing of an FDA advisory panel, which last month said there was sufficient evidence to go ahead."

 
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Gardasil HPV Vaccine approved for anal cancer prevention
 
Melissa Healy, Los Angeles Times
 
December 22, 2010
 
Gardasil, the vaccine that can prevent most cases of cervical cancer in girls, has won the FDA's blessing as a vaccine to prevent anal cancer, a rare but growing diagnosis in the United States.
 
The drug agency's approval for Gardasil as an anal cancer vaccine opens the way for the medication's maker, Merck and Co. Inc., to market the vaccine to boys and young men between the ages of nine and 26. The FDA's decision could theoretically double the number of children and young adults urged to take the vaccine. But physicians are most likely to recommend the vaccine first for boys and young men who are gay but have not yet become sexually active and for young men who may engage in sexual relations with other men.
 
While anal cancer affects both men and women, men who engage in homosexual sex are at greatest risk of contracting anal or genital warts, which can become cancerous over time. Clinical data presented by Merck to the FDA suggested that Gardasil may prevent 78% of anal lesions and anal cancer in men who have sex with men.
 
Meanwhile, girls starting at age 9 are already urged to get the vaccine to block the transmission of four strains of the human papilloma virus (HPV), which collectively account for 75% of cervical cancers, 70% of vaginal cancers and 50% of vulvar cancer cases. The federal government's Advisory Committee in Immunization Practices is deliberating on a proposal to extend that recommendation to include boys -- both as an indirect means of preventing the transmission of HPV to women and now, as protection for themselves against anal cancer.
 
Anal cancer is rare, with roughly 5,300 new diagnoses and 720 deaths from the disease each year. Treatment for this cancer typically involves surgery and radiation or chemotherapy. FDA's Dr. Karen Midthun called treatment for anal cancer "challenging," and said that the use of Gardasil could be "important" in driving down new diagnoses. Most of those cases are thought to spring from cases of HPV.(Twenty million Americans are infected and an additional 6 million yearly are expected to become infected.)
 
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FDA: Gardasil Approved to Prevent Anal Cancer
 
SOURCE U.S. Food and Drug Administration
SILVER SPRING, Md., Dec. 22, 2010 /PRNewswire-USNewswire/ --The U.S. Food and Drug Administration today approved the vaccine Gardasil 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 years.
 
Gardasil already is approved for the same age population for the prevention of cervical, vulvar, and vaginal cancer and the associated precancerous lesions caused by HPV types 6, 11, 16, and 18 in females. It is also approved for the prevention of genital warts caused by types 6 and 11 in both males and females. "Treatment for anal cancer is challenging; the use of Gardasil as a method of prevention is important as it may result in fewer diagnoses and the subsequent surgery, radiation or chemotherapy that individuals need to endure," said Karen Midthun, M.D., director of the FDA's Center for Biologics Evaluation and Research.
 
Although anal cancer is uncommon in the general population, the incidence is increasing. HPV is associated with approximately 90 percent of anal cancer. The American Cancer Society estimates that about 5,300 people are diagnosed with anal cancer each year in the United States, with more women diagnosed than men. 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 (MSM). 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 percent 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.
 
Individuals recommended for anal cancer screening by their health care provider should not discontinue screening after receiving Gardasil.
 
As of May 31, 2010, more than 65 million doses of Gardasil had been distributed worldwide, since its approval in 2006 according to the manufacturer, Merck and Co. Inc, of Whitehouse Station, N.J. The most commonly reported adverse events include fainting, pain at the injection site, headache, nausea, and fever.
 
Fainting is common after injections and vaccinations, especially in adolescents. Falls after fainting may sometimes cause serious injuries, such as head injuries. This can be prevented by keeping the vaccinated person seated for up to 15 minutes after vaccination. This observation period is also recommended to watch for severe allergic reactions, which can occur after any immunization.
 
For more information:
Gardasil Product Page
http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm094042.htm
 
News Release, Sept. 12, 2008 - FDA Approves Expanded Uses for Gardasil to Include Preventing Certain Vulvar and Vaginal Cancers
 
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2008/ucm116945.htm
 
News Release, Oct. 16, 2009 - FDA Approves New Indication for Gardasil to Prevent Genital Warts in Men and Boys
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2009/ucm187003.htm
 
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MERCK PRESS RELEASE:
 
US FDA Approves New Indication for Merck's HPV Vaccine, GARDASIL®
 
Business Wire (press release) - 2 hours ago
 
... announced today that the US Food and Drug Administration (FDA) has approved GARDASIL ® [Human Papillomavirus Quadrivalent (Types 6, 11, 16, ...
 
 
 
 
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