Sanofi Pasteur MSD seeks license extension for Gardasil

Sanofi Pasteur MSD has filed for an update of the license for the cervical cancer vaccine Gardasil to include the prevention of vulvar and vaginal cancers due to human papillomavirus types 16 and 18.

The European Medicines Agency (EMEA) has accepted the filing and has started its review.

In clinical studies, Gardasil prevented 100 per cent of pre-cancerous vulvar lesions and 100 per cent of pre-cancerous vaginal lesions related to human papillomavirus (HPV) types 16 or 18 through a mean follow up of three years after start of vaccination.

Gardasil is currently the only cervical cancer vaccine that directly targets the four HPV types 6, 11, 16 and 18.

It is estimated that types 6, 11, 16 and 18 cause 75 per cent of cervical cancer in Europe,  70 per cent of vulvar and vaginal cancers, 70 per cent of pre-cancerous and 35-50 per cent of early cervical lesions, 70 per cent of pre-cancerous vulvar and vaginal lesions and 90 per cent of genital warts.

It is estimated that 30,000 new cases of pre-cancerous vulvar and vaginal lesions related to HPV are diagnosed each year in Europe.

Vulvar and vaginal cancers collectively account for a significant proportion of all gynaecological cancers; in the UK, for example, they represent six per cent of all gynaecological cancer.

An increasing incidence of pre-cancerous vulvar lesions and vulvar cancer has been noted over the past 30 years. The incidence of vulvar carcinoma in situ increased by 400 per cent in the USA between 1973 and 2000; invasive vulvar cancer increased by 20 per cent during the same period.

Historically, vulvar cancer was seen almost exclusively in older women, however recent studies have shown that 20 per cent of these cancers now occur in women younger than 50 years. While vulvar cancer in older women mostly occurs without association to HPV, almost all vulvar cancers among younger women are HPV-related.

Professor Elmar Joura from the University of Vienna explained: "Precursors of vulvar and vaginal cancers are often not recognised. Their treatment to avoid a progression to cancer is challenging, can be disfiguring and requires long-term follow-up since recurrence is common. In addition, women may suffer anxiety, depression, sexual dysfunction and poor self-image."

Patrick Poirot, vice-president for Medical and Scientific Affairs at Sanofi Pasteur MSD, said: "We have developed Gardasil as a complete offer against a wide range of diseases that affect several genital organs. Starting with the prevention of cervical cancer as our first priority, we could now widen the benefits by helping protect women against vulvar and vaginal cancers."

Gardasil and GlaxoSmithKline's Cervarix are together predicted to generate sales of more than USD 4bn in 2012, according to a Lead Discovery report.