NEW DRUGS DRUG NEWS NEW DRUGS Cervical Cancer Vaccine

NEW DRUGS Cervical Cancer Vaccine The Food and Drug Administration (FDA) has approved Gardasil (Merck), the first vaccine developed to prevent cervical cancer, precancerous genital lesions, and genital warts caused by human papilloma virus (HPV) types 6, 11, 16, and 18 for females nine to 26 years of age. This agent was evaluated and approved in six months under the FDA’s priority review process for products with the potential to provide significant health benefits. The Center for American Progress calls this approval “one of the greatest public health victories since the polio vaccination.” A similar vaccine, produced by GlaxoSmithKline, has been shown to be effective for women up to 55 years of age. The Merck and GlaxoSmithKline vaccines have proved 100% effective against the two strains of HPV that account for 70% of the cases of cervical cancer in the U.S. The Merck vaccine may also be effective against strains that cause vaginal and vulvar cancers and is 99% ef fective against the two strains of HPV responsible for 90% of genital warts. Gardasil, a recombinant vaccine (containing no live virus), is given as three injections over a six-month period. Females are not protected if they have been infected with an HPV type before vaccination. Because Gardasil does not protect against less common HPV types not included in the vaccine, routine Pap screening remains critically important to detect precancerous cervical changes. Merck is conducting an ongoing study to evaluate Gardasil for males. For more information on this vaccine, please see this month’s Pharmaceutical Approval Update, page 404. Sources: FDA; Center for American Progress, June 8, 2006; www.fda.gov; www. fda.gov/womens/getthefacts/hpv.html. Generic Approvals