Cervical Cancer Vaccine May Be on the Horizon

Human papillomavirus (HPV) has been identified as the cause of cervical cancer, pre-cancers, benign cervical lesions, and genital warts. As one of the leading cancers among women, cervical cancer results in approximately 290,000 deaths worldwide each year. In the US, about 10,400 new cases will be diagnosed in 2005, with an estimated 3,700 deaths. Approximately 20 million American men and women are infected with HPV. In most people, HPV goes away on its own. In some, however, certain high-risk or oncogenic types of HPV can lead to cervical cancer.

A recent phase III study (FUTURE II) of more than 12,000 women in 13 countries has demonstrated the effectiveness of an investigational vaccine, which prevented 100% of high-grade cervical precancers and noninvasive cervical cancers associated with HPV types 16 and 18. HPV types 16 and 18 account for about 70% of cervical cancers. In addition to targeting HPV types 16 and 18, this quadrivalent vaccine also targets HPV types 6 and 11, which account for 90% of genital warts. These four HPV types can also cause benign cervical changes that result in abnormal Pap tests.

The study is part of an ongoing phase III program for the vaccine and involves more than 25,000 people in 33 countries. The US Food and Drug Administration (FDA) has recently given the proposed vaccine priority review status, which means a ruling on the new drug application in six months rather than the standard 10.