A phase 3 study showed that Gardasil, an investigational vaccine from Merck, prevented 100% of high-grade cervical precancers and noninvasive cervical cancers associated with human papillomavirus (HPV) types 16 and 18. This worldwide, prospective, randomized, double-blind, placebo-controlled study, known as FUTURE II, included more than 12,000 women, with 6082 receiving Gardasil and 6075 receiving a placebo. The study evaluated the incidence of HPV 16/18-related cervical precancers and noninvasive cancers and the cervical lesions related to these cancers, which are precursors to invasive squamous cell cervical cancer. In the group receiving a regimen of Gardasil, no cases of highgrade precancer and noninvasive cancer associated with HPV 16/18 were present, compared with 21 cases in the placebo group. Merck expects to submit a Biologics License Application to the FDA by the end of this year.
Ms. Farley is a freelance medical writer based in Wakefield, RI.
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