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【drug-news】Merck声明
Merck's Statement
May 9, 2007 6:24 p.m.
New England Journal of Medicine Publishes New Data on GARDASIL®, Merck's Cervical Cancer Vaccine
WHITEHOUSE STATION, N.J., May 9, 2007 - Today, the New England Journal of Medicine is publishing results from two Phase III studies of Merck's cervical cancer vaccine, GARDASIL [Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine]. In the first study, GARDASIL provided 100 percent protection against cervical, vaginal and vulvar diseases caused by the four HPV types GARDASIL is designed to protect against, HPV types 6, 11, 16, and 18. In the second study, GARDASIL provided 98 percent protection against advanced cervical pre-cancers caused by the two primary cancer-causing HPV types, HPV 16 and 18. These significant results, observed in 15- to 26-year-old women who were not infected with the relevant HPV types when they began the study, were sustained through an average of three years of participation in the trials, including an additional year of follow up since data were presented to the U.S. Food and Drug Administration (FDA) for approval of GARDASIL.
"In these two studies, GARDASIL demonstrated significant protection against serious HPV-related diseases, including high-grade cervical pre-cancers, in women not previously exposed to the relevant HPV types targeted by the vaccine," said Kevin Ault, M.D., associate professor, Division of Gynecologic Oncology, Department of Gynecology and Obstetrics, Emory University School of Medicine, Atlanta. "Widespread immunization of 11- to 26-year-old girls and women with GARDASIL, along with continued screening, will help decrease the burden of cervical cancer and other HPV-related diseases."
It is estimated that in 2007, cervical cancer will strike more than 11,000 women in the U.S. and nearly 500,000 women around the world. GARDASIL helps protect against the four HPV types - 6, 11, 16 and 18 - that cause the most disease, including 70 percent of cervical cancer cases and 90 percent of cases of genital warts. All four types cause a large number of "abnormal" Pap test results and low-grade cervical lesions.
"My fellow investigators around the world are proud of these data and their contribution to our understanding of the impact of GARDASIL on risk for development of cervical, vulvar, and vaginal diseases caused by HPV 6, 11, 16, and 18," said Eliav Barr, M.D., executive director of Biologics Clinical Research and head of the HPV Vaccine Program, Merck Research Laboratories. "In women not infected with the four HPV types targeted by GARDASIL, GARDASIL reduced cervical disease caused by the relevant HPV types. And, across the larger study population, GARDASIL also reduced the overall burden of cervical, vulvar, and vaginal HPV diseases caused by HPV types targeted by the vaccine and by other HPV types."
GARDASIL was approved by the FDA on June 8, 2006, and is recommended for use by girls and women ages 11 to 26 by the U.S. Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices. GARDASIL is indicated for the prevention of HPV types 16- and 18- related cervical cancer, non-invasive cervical cancer [cervical intraepithelial neoplasia (CIN) grade 3 and adenocarcinoma in situ (AIS)], cervical pre-cancers [cervical intraepithelial neoplasia (CIN) grade 2], vulvar pre-cancers [vulvar intraepithelial neoplasia (VIN) 2/3)] and vaginal pre-cancers [vaginal intraepithelial neoplasia (VaIN) 2/3], and for the prevention of genital warts and low-grade cervical lesions (CIN 1) caused by HPV types 6, 11, 16 and 18. GARDASIL is contraindicated in individuals who are hypersensitive to the active substances or to any of the excipients of the vaccine.
Studies assessed CIN 2/3, the most meaningful efficacy measure
The studies, FUTURE I and FUTURE II, are phase III, prospective, double-blind, placebo-controlled randomized studies conducted in 29 countries. The women who participated in the trials were 15 to 26 years old at enrollment; they received three doses of either GARDASIL or placebo at day one, month two and month six. The primary analyses of these trials evaluated the efficacy of GARDASIL compared to placebo in women who were free of infection with the relevant HPV types (6, 11, 16 and/or 18) when they started the study, remained free of infection with the relevant HPV types through month seven, received all three doses of GARDASIL within one year and had no protocol violations.
FUTURE I was designed to evaluate the impact of GARDASIL on the incidence of cervical lesions and pre-cancers (CIN 1-3), vulvar and vaginal external lesions and pre-cancers (VIN 1-3 and VaIN 1-3) and external genital warts caused by the four HPV types targeted by the vaccine (HPV 6, 11, 16 and 18). FUTURE II was designed to evaluate the impact of GARDASIL on pre-cancers and non-invasive cancers (CIN 2/3, AIS) caused by HPV 16 and 18. Prevention of advanced, or high grade cervical pre-cancerous lesions -- CIN 2/3 or AIS -- has been identified by the FDA and World Health Organization as the most meaningful indicator of cancer efficacy for a cervical cancer vaccine.
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作者:admin@医学,生命科学 2011-02-13 05:11
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