Gardasil uitbreiding indicatie vaginakanker
Sanofi Pasteur Msd
Gardasil®'s indication to be extended to
the prevention of precancerous vaginal lesions
In addition to cervical cancer prevention, Gardasil® provides girls and women with wide-ranging protection against HPV6,11,16,18-related genital diseases from the cervix to the vulvar and the vagina
Hoofddorp, 2 juni 2008 – The quadrivalent cervical cancer vaccine Gardasil® has received a positive opinion from the European Medicines Agency (EMEA) for an extended marketing authorisation to include the prevention of precancerous vaginal lesions.
The EMEA's Committee for Medicinal Products for Human Use (CHMP) recommended adding the prevention of precancerous vaginal lesions (VaIN 2/3) due to human papillomavirus (HPV) types 16 and 18. HPV types 16 and 18 cause about 90% of HPV-related vaginal cancer. , The EU Commission could now approve the extended marketing authorisation within weeks.
"Precancerous vaginal lesions are difficult to detect. The treatment to avoid progression to cancer is challenging and often requires ablative therapy, partial vaginectomy and radiotherapy in case of invasive cancer. Recurrence is common," explains Elmar Joura, professor of gynaeco-oncology at the University of Vienna. "In addition, women may suffer from anxiety, depression, sexual dysfunction and poor self-image, resulting in broken lives."
The supplemental indication would add to the current indications for Gardasil® which are the prevention of cervical cancer, precancerous cervical lesions (CIN2/3), precancerous vulvar lesions (VIN 2/3) and genital warts caused by HPV types 6, 11, 16 and 18.
"This extension validates our comprehensive approach in addressing HPV-related genital diseases and our robust clinical development", says Patrick Poirot, vice-president for Medical and Scientific Affairs, Sanofi Pasteur MSD. "Providing protection to the vulva and the vagina in addition to the cervix widens the benefits of vaccination with Gardasil® both for women and health authorities."
Final data from large phase II/III clinical studies confirmed the high and sustained efficacy of 100% of Gardasil® against vaccine virus type-related precancerous vulvar (VIN2/3) and vaginal lesions (VaIN2/3).