Published on FDA.gov (October 16, 2009)
The U.S. Food and Drug Administration today approved use of the vaccine Gardasil for the prevention of genital warts (condyloma acuminata) due to human papillomavirus (HPV) types 6 and 11 in boys and men, ages 9 through 26.
Each year, about 2 out of every 1,000 men in the United States are newly diagnosed with genital warts.
Gardasil currently is approved for use in girls and women ages 9 through 26 for the prevention of cervical, vulvar and vaginal cancer caused by HPV types 16 and 18; precancerous lesions caused by types 6, 11, 16, and 18; and genital warts caused by types 6 and 11.
HPV is the most common sexually transmitted infection in the United States and most genital warts are caused by HPV infection.
“This vaccine is the first preventive therapy against genital warts in boys and men ages 9 through 26, and, as a result, fewer men will need to undergo treatment for genital warts,” said Karen Midthun, M.D., acting director of the FDA’s Center for Biologics Evaluation and Research.
Gardasil’s effectiveness was studied in…
Continue reading25. November 2009
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Published on WorldPharmaNews.com (October 20, 2009)
GlaxoSmithKline (GSK) announced that the U.S. Food and Drug Administration (FDA) has approved CERVARIX® for the prevention of cervical pre-cancers and cervical cancer associated with oncogenic human papillomavirus (HPV) types 16 and 18 for use in girls and young women (aged 10-25).
“The approval of Cervarix will bring an important new cervical cancer vaccine to girls and young women,” said Deirdre Connelly, President, North American Pharmaceuticals, GlaxoSmithKline. “Immunisation with a vaccine such as CERVARIX – along with annual doctor visits and Pap tests – will help protect women from cervical cancer, the second leading cause of cancer death in women in their twenties and thirties.”
CERVARIX was shown to be 93 percent efficacious in the prevention of cervical pre-cancers (cervical intraepithelial neoplasia 2+/ CIN 2+ or adenocarcinoma in situ) associated with HPV 16 or 18, in women without evidence of current infection with, or prior exposure to, the same HPV type at the time of vaccination. The majority (approximately 75 percent) of cervical cancers in North America…
Continue reading25. November 2009
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Article by GINA KOLATA, Published on NYTimes.com (November 22, 2009)
A few years ago, an independent group that issues guidelines on cancer screening decided to review its recommendations for breast cancer. It had last issued guidelines in 2002, but things had changed — there was new science and researchers had become more sophisticated in analyzing existing data.
So the group, the U.S. Preventive Services Task Force, started what it thought would be a straightforward job: gathering the newest science and asking about the benefits and risks of breast cancer screening, the best time to start and how often women should be screened.
The group ended up recommending that most women forgo routine mammograms in their 40s and test every other year instead of every year.
The response was swift and angry. Professional groups, like the American College of Radiology, advocacy groups, like the American Cancer Society, and politicians said the guidelines would deprive women of a life-saving test. And some said the guidelines were politically motivated to save money.
Panel members have been taken aback by the response. Their work seemed almost mundane, they…
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25. November 2009
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