The European Commission has approved an amendment to the licence of UK drug giant GlaxoSmithKline’s cervical cancer vaccine Cervarix to better reflect the scope of protection it offers.
Marketing authorisation for the vaccine has been adjusted to show that its efficacy goes beyond the human papilloma virus strains (HPV) 16 and 18 to provide protection against 80% of all cervical cancers.
The amendment is based on data from the PATRICIA study that demonstrated Cervarix is effective against HPV strains 16, 18, 31, 33 and 45, which was not highlighted in its original indication.
The summary of product characteristics for Cervarix will be updated to include the prevention of precancerous lesions and cervical cancer causally related to certain strains of HPV, the group said.
Merck’s rival vaccine Gardasil is approved in Europe for protection against precancerous lesions in the genital area (cervix, vulva or vagina), cancer of the cervix and genital warts that are caused by infection with HPV types 6, 11, 16 or 18.
