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Gardasil cleared for anal cancer prevention in EU

Adds to existing cervical cancer indication for Sanofi’s vaccine
Sanofi Pasteur building

The European Commission has approved a new indication for Sanofi Pasteur MSD's human papillomavirus (HPV) vaccine Gardasil, giving the nod for it to be used in the prevention of anal cancer.

Gardasil is already approved in Europe to prevent cervical cancer and premalignant lesions in females aged over 9, but can now also be offered to both males and females who may be at risk of anal cancer. It is also approved to prevent genital warts.

Specifically, the EC has cleared Gardasil to prevent anal cancer and anal precancerous lesions – or anal intraepithelial neoplasia (AIN) - caused by HPV, recognising that most cases are caused by HPV types 16 and 18. The vaccine was given a green light by the US FDA for this indication in December 2010.

HPV infection is on the rise in the UK and according to data published earlier this month by Cancer Research UK it has fuelled a 300 per cent rise in anal cancer rates since the 1970s, with women more likely to be affected than men.

All told, 90 per cent of anal cancer cases are linked to the virus - which is often transmitted sexually - and Cancer Research UK suggests that the larger proportion of women affected could be linked to a reported rise in anal sex among heterosexual couples.

The approval "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," said Jean-Paul Kress, president of Sanofi Pasteur MSD.

All European countries currently have HPV vaccination programmes to prevent cervical cancer in girls, in common many other countries around the world. To date however only Australia has unveiled a programme - due to kick off in September - that also offers HPV vaccination to boys.

More widespread vaccination with Gardasil and GlaxoSmithKline's rival HPV vaccine Cervarix is advocated in some quarters to try to develop herd immunity to HPV and reduce the risk of not only cervical and anal cancers but others linked to the virus, such as penile and some oropharyngeal cancers.

Cervarix has also been shown in clinical trials to be effective in preventing anal cancer and AIN, although it has not yet been approved for this indication.

Article by
Phil Taylor

18th June 2014

From: Sales



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