Kidney Cancer Signs, Symptoms, Causes, Treatments
Sipuleucel-T
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Landmark Approval For Dendreon's Cancer Vaccine
The April 29 approval of Seattle-based Dendreon's prostate cancer vaccine, Provenge (sipuleucel-T), is being hailed as a victory for cancer immunotherapy. For Dendreon, the US Food and Drug Administration's (FDA) go-ahead marks the end of a tortuous regulatory path, marked not only by missteps by the company but also by controversy at the FDA, not least the decision in 2007 by the Center for Biologics Evaluation and Research (CBER) to act against its advisory panel's positive recommendations. After the turmoil of ad campaigns critical of the agency, picketing and lobbying by patient groups, death threats, lawsuits and even calls for a Congressional investigation (Nat. Biotechnol. 26, 1, 2008), the FDA issued a complete response letter on the earlier trials and requested further clinical evidence of efficacy. Dendreon then soldiered on with a phase 3 placebo-controlled trial (Immunotherapy for Prostate Adenocarcinoma Treatment; IMPACT), the results of which were submitted to FDA last November. On the basis of these data, which have yet to be published in a peer-reviewed journal, the agency finally gave Provenge its imprimatur, approving the first therapeutic vaccine for use in individuals with asymptomatic, or minimally symptomatic hormone refractory metastatic prostate cancer.
It remains unclear, however, whether Dendreon's decade-long struggle to pass regulatory muster has clarified the path of oversight for other cancer vaccines or even whether autologous cellular vaccines will rival the success of 'off-the-shelf' vaccines or other types of adjunct therapies, such as antibodies or small molecules. Therapeutic cancer vaccines are a diverse group of products; they can be cellular or acellular (peptides, proteins, DNA), be targeted against a single antigen or groups of antigens, use viruses or other scaffolds to present antigens or use patient cells or cell lines (Nat. Biotechnol. 27, 129–139, 2009).
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