A phase 3 study showed that Gardasil, an investigationalvaccine from Merck, prevented 100% of high-grade cervicalprecancers and noninvasive cervical cancers associated withhuman papillomavirus (HPV) types 16 and 18. This worldwide,prospective, randomized, double-blind, placebo-controlledstudy, known as FUTURE II, included more than12,000 women, with 6082 receiving Gardasil and 6075receiving a placebo. The study evaluated the incidence ofHPV 16/18-related cervical precancers and noninvasive cancersand the cervical lesions related to these cancers, whichare precursors to invasive squamous cell cervical cancer. Inthe group receiving a regimen of Gardasil, no cases of highgradeprecancer and noninvasive cancer associated withHPV 16/18 were present, compared with 21 cases in theplacebo group. Merck expects to submit a Biologics LicenseApplication to the FDA by the end of this year.
Ms. Farley is a freelance medical writer based in Wakefield, RI.