Cancer Vaccines
Merck Submits New Cross-Protection Data for GARDASIL to the FDA and Seeks New Indications for Vaginal and Vulvar Cancers
Published in Cancer Weekly, May 1st, 2007
Merck announced the Company has submitted a supplemental Biologics License Application (sBLA) for GARDASIL(R) (Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine) to the U.S. Food and Drug Administration (FDA) to update the labeling for GARDASIL, the cervical cancer vaccine. The new submission for GARDASIL includes efficacy data showing some protection against additional cervical cancer causing HPV types responsible for greater than 10 percent of cervical cancers, data on protection against additional gynecological cancers -- vaginal and vulvar, and data on immune memory.
GARDASIL is the world's first and only cervical cancer vaccine, and is...
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Source: Cancer Weekly (2007-05-01)
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