GSK's Cervarix receives positive opinion in Europe for cervical cancer

Cervical Cancer :: GSK's Cervarix receives positive opinion in Europe for cervical cancer

GlaxoSmithKline (GSK) announced that its cervical cancer candidate vaccine received a positive opinion from the European Committee for Human Medicinal Products (CHMP) for the prevention of precancerous lesions (high grade cervical intraepithelial neoplasia - CIN grades 2 and 3) and cervical cancer causally related to human papillomavirus types 16 and 18.

This proposed indication is based on data generated in girls and women aged between 10 and 25.

The positive opinion was reached after the CHMP reviewed data from clinical trials in almost 30,000 females, including data from the largest Phase III cervical cancer vaccine efficacy trial to date[1], which demonstrated that the candidate vaccine showed an excellent efficacy profile and was generally well tolerated.

?Today?s positive opinion from the CHMP is great news for women across Europe. It is a significant step towards achieving our ambition - to provide women with protection against cervical cancer. Coupled with the excellent clinical trial results published recently, this news is further evidence of the great potential ofour cervical cancer candidate vaccine,? said JP Garnier, Chief Executive Officer of GSK.

The GSK cervical cancer candidate vaccine 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?s cervical cancer candidate vaccine has been shown to be generally well-tolerated.