GSK's Adjuvanted Cervical Cancer Vaccine Receives Favorable Recommendation from FDA Advisory Committee

October 7, 2009

The US Food and Drug Administration?s Vaccines and Related Biological Products Advisory Committee voted that clinical data support both the efficacy and safety of Cervarix, GlaxoSmithKline?s (GSK, Middlesex, UK) candidate cervical cancer vaccine.

The US Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee voted that clinical data support both the efficacy and safety of Cervarix, GlaxoSmithKline’s (GSK, Middlesex, UK) candidate cervical cancer vaccine. The Committee’s favorable recommendation, although not binding, will be considered by the FDA in its final review of the biologics license application for the candidate vaccine. If approved, the FDA will determine final prescribing information.

GSK designed Cervarix with its ASO4 adjuvant system to deliver high and sustained levels of antibodies aimed at providing long-term protection against cancer-causing human papillomavirus (HPV) types, although the exact level of antibodies that confer protection is not known. Protection has been shown through 6.4 years and ongoing clinical studies continue to assess duration of protection. ASO4 enhances the body's immune response to the antigens contained in the vaccine. This response provides protection at the cervix, where natural antibody response to infection may not adequately protect against future infections with the same virus type.

Cervarix was shown to be effective and well tolerated in girls and young women for the prevention of cervical pre-cancers and cervical cancer related to HPV types 16 and 18, the two most common virus types that cause cervical cancer. The committee also discussed data demonstrating the efficacy of Cervarix against additional cancer-causing virus types.