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GSK's Cervarix approved in first major market
24 May 2007
GlaxoSmithKline's cervical cancer vaccine Cervarix has been approved in Australia, its first major market.
Australia's drugs regulator, the Therapeutic Goods Administration (TGA), has licensed Cervarix for the prevention of cervical cancer and precancerous lesions associated with HPV virus types 16 and 18, which are responsible for about 70% of cervical cancer.
The vaccine has been licensed for use in females aged 10-45 years of age. Jean Stephenne, president of GSK Biologics, pointed out that it is the first cervical cancer vaccine that is explicitly indicated for women over the age of 26.
Merck & Co/Sanofi Pasteur MSD's rival vaccine, Gardasil, which beat Cervarix to the market, is approved for girls and women aged between nine and 26. The focus of vaccination so far has been on children and adolescents who have not yet been exposed to the HPV virus through sexual activity, since both Gardasil and Cervarix are prophylactic and not therapeutic cancer vaccines.
In a trial of 776 women, Cervarix demonstrated 100% efficacy in preventing pre-cancerous lesions due to HPV types 16 and 18 for up to 5.5 years in women 15-25 years of age.
Results from a 666-patient Phase III study aired at last year's ASCO meeting in June were the first in women over the age of 25. In the study, all women in four age groups - 15-25, 26-35, 36-45 and 46-55 - developed detectable antibodies against HPV-16 and HPV-18, although antibody titres were lower in the older age groups.
GSK has filed Cervarix in both the EU and US and the company hopes to launch the product in the EU this year. It should hear soon whether the vaccine has received priority review status from the FDA, and if it is granted this it could secure US approval by the end of the year.
"We believe that available data from clinical trials supports use of the vaccine in women 10-55, whether it will be approved for use is dependant on the regulators in different countries," GSK said.
Although beaten to the market, GSK hopes that Cervarix will show benefits over Gardasil and began a head-to-head study in January (Scrip No 3227, p 16). The primary objective is to compare immune responses to HPV types 16 and 18, and the first data is expected from in the first quarter of next year. Merck has said however that the results of a head-to-head study examining only immunogenicity will not provide an equivalent to efficacy in prevention of disease.
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