Gardasil HPV vaccine approved for the prevention of anal cancer

EC grants a new indication for Gardasil.

19 June, 2014 12:36 PM

Sanofi Pasteur MSD announced today that the European Commission has granted marketing authorisation for the use of Gardasil® (human papillomavirus vaccine [types 6, 11, 16, 18] [recombinant, adsorbed]) for the prevention of anal precancerous lesions and anal cancers causally related to certain oncogenic human papillomavirus (HPV) types in both males and females.Gardasil is already approved from 9 years of age for the prevention of cervical cancer and premalignant genital lesions (cervical, vulvar and vaginal) causally related to certain oncogenic HPV types in females. It is also approved for the prevention of genital warts causally related to specific HPV types in both males and females.HPV is a virus that causes a number of diseases and cancers, including cervical cancer in females and anal cancer in both males and females. This new indication acknowledges the efficacy of Gardasil, targeting the high-risk HPV types 16 and 18 which cause the vast majority of anal cancers.(1)“Thanks to the new indication, Gardasil® provides today a unique opportunity for the prevention of anal precancers and anal cancer," said Dr Jean-Paul Kress, President of Sanofi Pasteur MSD. “The possibility to prevent anal cancer further reinforces the need for widespread vaccination of both males and females against HPV, especially since there are currently no other routine measures or screening programmes available for prevention of anal cancers," concluded Dr Kress.Gardasil is a quadrivalent HPV vaccine that helps to protect people from HPV-related cancers of the cervix and anus, genital precancerous lesions and genital warts, with demonstrated protection in real-life population studies.(2–4) Launched in 2006, it is the most widely used HPV vaccine globally with approximately 152 million doses distributed to date.(5)


  1. Alemany L, et al. Human papillomavirus DNA prevalence and type distribution in anal carcinomas worldwide. Int J Cancer 2014 [Epub ahead of print].
  2. Brotherton JML, et al. Early effect of the HPV vaccination programme on cervical abnormalities in Victoria, Australia: an ecological study. Lancet 2011;377:2085–92.
  3. Read TRH, et al. The near disappearance of genital warts in young women 4 years after commencing a national human papillomavirus (HPV) vaccination programme. Sex Transm Infect 2011; 87:544–7.
  4. Markowitz LE, et al. Reduction in Human Papillomavirus (HPV) Prevalence Among Young Women Following HPV Vaccine Introduction in the United States, National Health and Nutrition Examination Surveys, 2003–2010. JID, 2013;208[3]:385–93.
  5. SPMSD, internal data, June 2014.®-hpv-vaccine-approved-prevention-anal-cancer