The US Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) has given its backing to GlaxoSmithKline’s (GSK) candidate cervical cancer vaccine Cervarix.
The VRBPAC committee voted that clinical data supports the efficacy and safety of Cervarix, which has been shown to be highly effective and well tolerated in girls and young women for the prevention of cervical pre-cancers and cervical cancer related to human papillomavirus (HPV) types 16 and 18.
The Committee’s recommendation, although not binding, will be considered by the FDA in its final review of the candidate vaccines’ Biologics License Application.
GSK North American Vaccine Development vice-president and director Barbara Howe said that this is an important step in cancer prevention for the millions of girls and young women at risk from cervical cancer.
“Cervical cancer is a devastating disease that is responsible for thousands of deaths in US women each year,” Howe said.
In March 2009, GSK submitted final data from what has been the largest efficacy trial of a cervical cancer vaccine to date and involved nearly 30,000 women from 30 countries.