Regulators in Europe have given the green light for Sanofi Pasteur MSD’s cervical cancer vaccine Gardasil to be used for the prevention of anal cancer.

Specifically, the European Commission has granted marketing authorisation for the use of Gardasil for the prevention of anal precancerous lesions and anal cancers causally related to certain oncogenic human papillomavirus types in both males and females. Some 6,800 new cases of anal cancer are estimated to occur annually in Europe, among which about 75-80% are attributable to HPV types 16 and 18.

Sanofi Pasteur MSD, a European vaccines joint venture between the French drugmaker and Merck & Co, said that according to population-based studies, anal cancers are more frequent in women than in men, with over 60% of cases occurring in the latter. The incidence of anal cancer is high among men who have sex with men, however the company cited a study which estimated that 53% of male anal cancers in occurred in heterosexuals.

Paul Kress, president of Sanofi Pasteur MSD, said the new indication for Gardasil, which provides “a unique prevention tool for such a serious oncological disease”, further “reinforces the need for widespread vaccination of both males and females against HPV”. He argued that this is especially especially important “since there are currently no other routine measures or screening programs available for prevention of anal cancers”.

All European countries currently implement cervical cancer/HPV vaccination programmes for girls, mostly in schools, although starting in September, Austria will vaccinate all boys and girls Launched in 2006, Gardasil is the most widely used HPV vaccine worldwide, with approximately 152 million doses distributed to date, followed by GlaxoSmithKline’s Cervarix.