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In a complete response letter from the FDA, Merck & Co has been asked to provide long-term efficacy data for its therapeutic cancer vaccine Gardasil (human papillomavirus (HPV) quadrivalent (types 6, 11, 16, 18) vaccine, recombinant), for the prevention of cervical cancer in women aged 27 to 45. Gardasil was approved by the FDA in June 2006 for women aged nine to 26 for the prevention of cervical cancer and genital warts caused by HPV (types 6, 11, 16, 18).
The supplemental Biologics License Application submission for Gardasil was based on data collected during an average of 24 months following enrollment into a study investigating Gardasil for the prevention of cervical cancer in women aged 27 to 45. In June 2008, the FDA withheld approval after completing its review of the initial response data that Merck provided. After withholding approval once again, the agency has recommended that Merck submits additional data when a 48-month study on a test group has been completed. Merck anticipates providing a response to the FDA in Q4 2009.
Cervical cancer accounts for less than a fifth of all gynecological cancers, but in developed countries, mass-screening programs via the Papanicolaou (Pap) smear test have been highly effective in reducing the incidence of invasive cervical tumors. Thus there is a strong therapeutic drive towards the prevention of cervical cancer. Importantly, the limited availability of effective treatment options for advanced stage cervical cancers means that there remains a high unmet need for more effective therapies or, conversely, more effective prevention strategies.
Gardasil is likely to see competition from GlaxoSmithKline's anti-HPV vaccine Cervarix, which is currently in pre-registration in the US and already approved for use in the prevention of HPV-related cervical cancer (types 16 and 18) in the EU (September 2007) and other worldwide markets. However, an FDA review of Cervarix may progress into 2010 as GlaxoSmithKline plans to submit Phase III trial data in the second half of 2009. In the meantime, Gardasil may continue to gain market share for use in younger females, a population for which it is already FDA approved.
Merck & Co may, however, struggle to convince health insurers to cover Gardasil for older women, given that its effectiveness seems to be lower in this population and for women that have already been exposed to HPV. Although the incidence of cervical cancer is relatively low, women with HPV infection have a 50- to 100-fold greater risk of developing this deadly disease, leaving prevention crucial. The uncertainty surrounding the US label expansion will remain until full data are available from the 48-month trial.
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