Gardasil vaccine given thumbs up by FDA for treatment of other cancers

Gardasil vaccine given thumbs up by FDA for treatment of other cancers

Gardasil, the human papillomavirus vaccine, has been given approval by the U.S. Food and Drug Administration (FDA) for prevention of cancer of the anus and related precancerous lesions, the agency said in a news release today. The FDA has previously approved Gardasil for cervical, vaginal and vulvar cancers in women and also for genital warts in both men and women. Both the old and new indications for the drug covers those aged 9 to 26. Four types of human papillomavirus (HPV) namely 6, 11, 16 and 18 are responsible for 90 percent of malignancies of the anal region. "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 Dr. Karen Midthun in a statement. She is the director of the Center for Biologics Evaluation and Research of the FDA.

The agency based the decision to expand the use of the vaccine partly on Merck's study which showed that Gardasil was 78 percent effective in preventing the development of that type of cancer among men and women homosexuals. This new indication is for a cancer type that is rare but increasing. The National Cancer Institute says that about 5,300 people are diagnosed and 72 die annually from the disease. The incidence of this cancer is higher among men who have sexual intercourse with men where 40 cases for every 100,000 are documented. For those with HIV among the same group, the rate rises further to 80 for every 100,000 cases. The Advisory Committee on Immunization Practices has yet to decide on recommending vaccination for young men and women.

Posted by George Daniels on Sunday December 26 2010, 1:09 AM EDT. Ref: MSNBC. All trademarks acknowledged. Filed under Featured News, Health. Comments and Trackbacks closed. Follow responses: RSS 2.0