GlaxoSmithKline yesterday said that its cervical cancer vaccine Cervarix has been given the thumbs up from Europe’s scientific advisory panel, the Committee for Human Medicinal Products, to prevent precancerous lesions and cervical cancer caused by human papillomavirus types 16 and 18 in females aged 10-25.
The panel reviewed data from clinical trials in almost 30,000 females, including data from the largest Phase III cervical cancer vaccine efficacy trial to date, involving more than 18,600 women. The results, published in The Lancet recently, showed that Cervarix was almost 100% effective in preventing precancerous lesions caused by HPV 16 and 18.
GlaxoSmithKline's Chief Executive Officer, JP Garnier, said: "Coupled with the excellent clinical trial results published recently, this news is further evidence of the great potential of our cervical cancer candidate vaccine." But the company has some tough competition in the shape of Merck & Co’s already-marketed Gardasil. Indeed it is taking this so seriously that it has planned a major head to head study to evaluate the immunogenicity of the two vaccines – primarily in women up to 26 years of age and secondarily in women aged 27-35 and 36-45. Results are anticipated 12 months following completion of patient enrollment.
Both vaccines employ the use of adjuvants, which boost the ability of an antigen to stimulate an immune response. But, while Merck's Gardasil uses an aluminum salt adjuvant, Cervarix uses a novel adjuvant known as AS04, which GSK is hoping to prove will give its vaccine an edge over its rival.
Final approval from the European Commission could now come in the next three to four months. Cervarix is already available in Australia after a first approval there, but the world’s largest pharmaceutical market – the USA – is not expected to give it the green light until 2008. Recently the Food and Drug Administration refused to give the vaccine a fast-track review on the basis that it does not meet a major unmet medical need or offer a significant advance on current therapy.
Cervical cancer is the second leading cause of cancer in women under 45, and causes over 270,000 deaths worldwide per year. HPV types 16 and 18 are responsible for approximately 71.5% of cervical cancers in Europe.