The European Commission granted a new indication for Gardasil®, for the prevention of anal cancer and anal precancerous lesions caused by specific oncogenic HPV types in both females and males
LYON, France I June 18, 2014 I Sanofi Pasteur MSD announced today that 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 (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 Human Papillomavirus (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 properties of Gardasil®, targeting the high-risk HPV types 16 and 18 which are causing the vast majority of anal cancers.(1)
"Thanks to the new indication for anal cancer, Gardasil provides today a unique prevention tool for such a serious oncological disease, 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 programs 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.(2,3,4) Launched in 2006, it is the most widely used HPV vaccine worldwide with approximately 152 million doses distributed to date.(5) The number of doses administered is not known.
About anal cancer
Approximately 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.(6-8) According to population-based studies, anal cancers are more frequent in women than in men, with over 60% of cases occurring in women.(6) In men, the incidence of anal cancer is higher among men who have sex with men (MSM), however a population based study estimated that 53% of male anal cancers in occurred in heterosexual men.(8)
The incidence of anal cancer has been continuously increasing over recent decades, both amongst men and women, in industrialized countries, in general, and in Europe, in particular.(8)
Prevention of anal cancer
The efficacy of GARDASIL® against anal disease - anal intraepithelial neoplasia (AIN) and anal cancer - was evaluated in a population of 598 men who have sex with men between 16 and 26 years of age. The primary analysis was conducted in the per-protocol efficacy (PPE) population, which consisted of individuals who received all three vaccinations within one year of enrolment, did not have any major deviations from the study protocol, and were naïve to HPV types 6, 11, 16 and 18 when they started the study and remained free of infection from these four HPV types through one month after receiving their last vaccine dose.(9)
The efficacy of GARDASIL in reducing the incidence of anal precancerous lesions grades 2/3 (AIN 2/3) related to vaccine HPV types 6, 11, 16 and 18 was 74.9% (95 % CI: 8.8, 95.4) and 86.6% (95 % CI: 0.0, 99.7) for the anal precancerous lesions grades 2/3 (AIN 2/3) related to the 2 oncogenic vaccine HPV types 16 and 18.(9)
The CHMP acknowledged the extrapolation of the efficacy of Gardasil in preventing AIN 2/3 from the MSM population to healthy heterosexual men (HM) and women.
About HPV vaccination programmes
All European countries currently implement cervical cancer/HPV vaccination programmes for girls, many in a schools based setting. Austria's HPV vaccination programme starting in September 2014 will vaccinate all boys and girls against HPV with Gardasil. For further details of European vaccination programmes visit ecdc website at http://www.ecdc.europa.eu/
Gardasil®, manufactured by Merck, is a quadrivalent vaccine for protection against cancer of the cervix and the anus, and other genital diseases caused by the human papillomavirus types 6, 11, 16 and 18: precancerous lesions of the cervix (CIN2/3), precancerous lesions of the anus (AIN 2/3), precancerous lesions of the vulva (VIN2/3) and vaginal (VaIN2/3) and genital warts (condyloma acuminata).(9)
About Sanofi Pasteur MSD http://www.spmsd.com
Sanofi Pasteur MSD is a European joint venture formed between Sanofi Pasteur (the vaccine division of Sanofi) and Merck (known as MSD outside the United States and Canada). Combining innovation and expertise, Sanofi Pasteur MSD is the only European pharmaceutical company dedicated exclusively to the distribution of vaccines. Sanofi Pasteur MSD makes use of the combined expertise resulting from Sanofi Pasteur and Merck's research to focus on the development of new vaccines in Europe in order to produce the most effective, most acceptable and better tolerated vaccines.
* United Nations European Region
1. Scholefield JH, Castle MT, Watson NF. Malignant transformation of high grade anal intraepithelial neoplasia. Br J Surg 2005;92:1133-6.
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: 544-547.
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, 385-393.
5. SPMSD, internal data, June 2014.
6. Forman D, de Martel C, Lacey CJ, Soerjomataram I, Lortet-Tieulent J, Bruni L, et al. Global burden of human papillomavirus and related diseases. Vaccine 2012;30 Suppl 5:F12-23.
7. de Martel C, Ferlay J, Franceschi S, Vignat J, Bray F, Forman D, et al. Global burden of cancers attributable to infections in 2008: a review and synthetic analysis. Lancet Oncol 2012;13(6):607-15.
8. De Vuyst H, Clifford GM, Nascimento MC, Madeleine MM, Franceschi S. Prevalence and type distribution of human papillomavirus in carcinoma and intraepithelial neoplasia of the vulva, vagina and anus: a meta-analysis. Int J Cancer 2009;124(7):1626-36.
9. Gardasil SmPC, June 2014.
SOURCE: Sanofi Pasteur MSD