GSK’s cervical cancer vaccine backed by EU

The positive opinion was reached after the the European Committee for Human Medicinal Products reviewed data from clinical trials in almost 30,000 females, including data from the largest Phase III cervical cancer vaccine efficacy trial to date, which demonstrated that Cervarix showed an excellent efficacy profile and was generally well tolerated.

Cervarix will now be proposed for final approval by the European Commission and a marketing authorisation could be granted in the coming months.

To date, over 40,000 women have participated or are currently taking part in clinical trials to evaluate the efficacy and immunogenicity of GSK’s cervical cancer candidate vaccine. In completed clinical trials, GSK says its cervical cancer candidate vaccine has been shown to be generally well-tolerated.