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Editorial

Nature Reviews Clinical Oncology 4, 381 (1 July 2007) | doi:10.1038/ncponc0854

The Provenge|[reg]| decision

Vincent T DeVita

On 9 May 2007 the FDA decided not to approve the prostate cancer vaccine Provenge|[reg]| (Dendreon Corporation, Seattle, WA), despite the recommendation to approve it by its own advisory committee. This decision was taken because the two small studies presented to the advisory committee, one of which has been published, failed to meet their primary end points (Small EJ et al. [2006] J Clin Oncol 24: 3089–3094).