New Gardasil approval
December 24, 2010
THE FDA has approved Gardasil
vaccine for the prevention of anal
cancer and associated
precancerous lesions due to the
human papillomavirus (HPV) types
6, 11, 16, and 18, for people aged
between 9 - 26 years.
The new approval follows a
randomised controlled trial which
found that Gardasil was 78%
effective in the prevention of HPV
16- and 18-related AIN.
“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.
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