GSK European Commission amends licence for Cervarix®

GlaxoSmithKline (GSK)GlaxoSmithKline (GSK) confirmed that the European Commission has granted Marketing Authorisation to amend the licence for its cervical cancer vaccine, Cervarix®. The approval from the European Commission is important as it recognises the extent of cervical cancer protection demonstrated by Cervarix®, which was not highlighted by the previous indication. The licence amendment is supported by data from the largest efficacy trial of a cervical cancer vaccine conducted to date, the PATRICIA study, and acknowledges that Cervarix® has shown efficacy beyond HPV 16 and 18, the two virus types contained in the vaccine.

The summary of product characteristics (SPC) for Cervarix® will be updated to include the prevention of precancerous lesions and cervical cancer causally related to certain strains of the human papillomavirus (HPV) and will reflect data showing efficacy against the two vaccine types contained in the vaccine (HPV 16 and 18) and the three next most common cancer-causing virus types (HPV 31, 33 and 45).* Together these five HPV types (16, 18, 31, 33 and 45) account for 80 percent of all cervical cancers.

* Vaccine efficacy is different for each of the HPV types 16, 18, 31, 33 and 45, and varies in different cohorts and endpoints.

GlaxoSmithKline Biologicals (GSK Biologicals), GlaxoSmithKline's vaccines business, is one of the world's leading vaccine companies and a leader in innovation. The company is active in vaccine research, development and production with over 30 vaccines approved for marketing and 20 more in development - both in the prophylactic and therapeutic fields. For further information please visit

Cervarix® is a registered trademark of the GlaxoSmithKline group of companies.