Anticancer vaccine approved

In a significant victory against cancer, FDA has approved the first vaccine developed to prevent cervical cancer, precancerous genital lesions and genital warts. Gardasil was approved for use in females 9-26 years of age after undergoing FDA's priority review process - a process for fast-tracking products with potential to provide significant health benefits.

"Today is an important day for public health and for women's health, and for our continued fight against serious life-threatening diseases like cervical cancer," said Alex Azar, deputy secretary, US Department of Health and Human Services. Worldwide, cervical cancer is the second most common cancer in women; it is estimated to cause over 470,000 new cases and 233,000 deaths each year.

HPV is a virus that can lead to various problems in the reproductive system, including genital warts and cervical cancer. For most women, the body's own defense system will clear the virus and infected women do not develop related health problems. However, some HPV types can cause abnormal cells on the lining of the cervix that years later can turn into cancer.

The vaccine is effective against HPV types 16 and 18, which cause approximately 70 per cent of cervical cancers and against HPV types 6 and 11, which cause approximately 90 per cent of genital warts.

"This vaccine . . . strikes at the infections that are the root cause of many cervical cancers," said Andrew C. von Eschenbach, acting commissioner of food and drugs. "The development of this vaccine is a product of extraordinary work by scientists as well as by FDA's review teams to help facilitate the development of very novel vaccines to address unmet medical needs."

www.fda.gov