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FDA committee: Hormone-refractory PCa agent shows 'substantial evidence' of efficacy, safety

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The FDA’s Office of Cellular, Tissue and Gene Therapies Advisory Committee has recommended to the FDA that there is substantial evidence of efficacy and safety of sipuleucel-T (Provenge) for patients with asymptomatic, metastatic hormone-refractory prostate cancer.

The FDA’s Office of Cellular, Tissue and Gene Therapies Advisory Committee has recommended to the FDA that there is substantial evidence of efficacy and safety of sipuleucel-T (Provenge) for patients with asymptomatic, metastatic hormone-refractory prostate cancer. If the FDA concurs with the committee’s report, sipuleucel-T would be the first active cellular immunotherapy and the first biologic approved to treat prostate cancer.

Dendreon Corp., manufacturer of sipuleucel-T, anticipates a decision by mid-May.

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