GlaxoSmithKline gets amended license for Cervarix; initiates Ph III study of shingles vaccine

UK pharma giant GlaxoSmithKline (GSK; L) says that the European Commission has granted Marketing Authorisation to amend the licence for its cervical cancer vaccine, Cervarix. The approval is important, the company says, 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% of all cervical cancers.