GlaxoSmithKline has submitted a BLA to the FDA for Cervarix (human papillomavirus vaccine, AS04 adjuvant-adsorbed), its cervical cancer vaccine. If licensed, the vaccine will be indicated for the prevention of cervical cancer and precancerous lesions associated with the most common cancer-causing human papillomavirus types. The proprietary adjuvant system called AS04 is intended to enhance immune response and increase duration of protection.

The BLA includes data from clinical trials that included almost 30,000 females 10 to 55 years of age and reflects an ethnically diverse population. The submission also contains data from the largest Phase III cervical cancer vaccine efficacy trial to date, which was conducted around the world in more than 18,000 females 15 to 25 years of age.