Late Breaking News: FDA Advisory Panel Recommends Approval of GSK's Cervical Cancer Vaccine, Cervarix®
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The U.S. Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted that clinical data support both the efficacy and safety of Cervarix®, GlaxoSmithKline (GSK) cervical cancer vaccine.
In a press release, the company announced that “Cervarix was shown to be highly effective and well tolerated in girls and young women for the prevention of cervical pre-cancers and cervical cancer related to human papillomavirus (HPV) types 16 and 18, the two most common virus types that cause cervical cancer. The committee also discussed data demonstrating the efficacy of Cervarix against additional cancer-causing virus types.”
The Committee’s favorable recommendation, although not binding, will be considered by the FDA in its final review of the Biologics License Application (BLA) for the candidate vaccine.
In March 2009, GSK submitted final data from its Phase III pivotal study (HPV-008), the single largest efficacy trial of a cervical cancer vaccine to date. The file included data from clinical trials in more than 30 countries involving nearly 30,000 participants receiving Cervarix, which reflect an ethnically and racially diverse population and a broad range of women. It also included a thorough safety assessment relevant to 10-25 year old girls and young women.
Cervarix® has been approved in nearly 100 countries around the world, including the 27 member states of the European Union (EU), Australia, Brazil, South Korea, Mexico and Taiwan. Licensing applications have been submitted in more than 20 additional countries, including Japan and the United States. GSK also received World Health Organization (WHO) prequalification in July 2009.
The likely approval will provide girls and women with an alternative to Merck’s cervical cancer vaccine Gardasil which has been on the market for almost two years. Gardasil has recently come under fire by religious and anti-vaccine groups and sales have been lackluster lately. It will be interesting what effect if any Cervarix will have on the US anti-HPV/cervical cancer market. That said, I doubt whether Merck executives will be sleeping as well as they have been prior to today’s advisory panel recommendation!
For a great comparison of the two vaccines check out an article in today's New York Time business section.
Until next time...
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