Merck Files For FDA Approval To Market HPV Vaccine Gardasil For Vaginal, Vulvar Cancers

Main Category: Cervical Cancer / HPV Vaccine
Also Included In: Women's Health / Gynecology
Article Date: 20 Apr 2007 - 3:00 PDT

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Merck on Tuesday in a statement announced that it has submitted an application to FDA for extended approval of its human papillomavirus vaccine Gardasil to help prevent vaginal and vulvar cancers, the AP/BusinessWeek reports (AP/BusinessWeek, 4/17). Gardasil in clinical trials has been shown to be 100% effective in preventing infection with strains 16 and 18, which together cause about 70% of cervical cancer cases, and about 99% effective in preventing HPV strains 6 and 11, which together with strains 16 and 18 cause about 90% of genital wart cases, among women not already infected with these strains. FDA in July 2006 approved Gardasil for sale and marketing to girls and women ages nine to 26, and CDC's Advisory Committee on Immunization Practices later that month voted unanimously to recommend that girls ages 11 and 12 receive the vaccine (Kaiser Daily Women's Health Policy Report, 4/16). According to a study presented in June 2006 at a meeting of the American Society of Clinical Oncology in Atlanta, Gardasil protects against vaginal and vulvar cancers. Jorma Paavonen of the University of Helsinki at the conference said that physicians randomly assigned 18,000 women to receive the vaccine or a placebo, and they found that 24 women who received the placebo after two years developed vaginal or vulvar cancer but no vaccinated women did. About 80% of people with vaginal and vulvar cancer also test positive for HPV (Kaiser Daily Women's Health Policy Report, 6/5/06). According to Merck, vaginal and vulvar cancers account for about 3% and 4% of gynecological cancers, respectively. The company said its new FDA application includes efficacy data showing some protection against additional cervical cancer-causing HPV types, as well as data on protection against vaginal and vulvar cancers (Reuters, 4/17). Merck said FDA within 60 days will determine whether it will accept the application for review. If the agency reviews the application, a decision could come within 10 months of the filing date, the AP/BusinessWeek reports (AP/BusinessWeek, 4/17).

GlaxoSmithKline's HPV Vaccine Cervarix Effective for More Than Five Years
In related news, GlaxoSmithKline's experimental HPV vaccine Cervarix has been found to be effective in preventing HPV strains 16 and 18 for more than 5.5 years, according to data presented on Tuesday at a meeting of the American Association for Cancer Research in Los Angeles, Dow Jones/MarketWatch reports (Berton, Dow Jones/MarketWatch, 4/17). Cervarix also has been shown to be 100% effective in protecting against HPV strains 16 and 18. Researchers in a 2006 study, published in the online edition of the journal Lancet, found that Cervarix prevented infection with HPV strains 31 and 45, which together with strains 16 and 18 cause more than 80% of cervical cancer cases (Kaiser Daily Women's Health Policy Report, 3/30). The data presented Tuesday were based on an extended follow-up analysis of 776 girls and women ages 15 to 25 that participated in an earlier trial (Dow Jones/MarketWatch, 4/17). Cervarix also showed 68% efficacy in preventing all precancerous lesions, regardless of the type of HPV detected, the study found (Reuters Health, 4/17). In addition, it showed 38% efficacy against abnormal Pap tests (Dow Jones/MarketWatch, 4/17). GSK in March filed for FDA approval of Cervarix. The company has recently applied for European approval and expects a decision in the coming months (Kaiser Daily Women's Health Policy Report, 3/30).

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