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Centers for Medicare & Medicaid Services

As described on the FDA website at http://www.fda.gov/BiologicsBloodVaccines/CellularGeneTherapyProducts/ApprovedProducts/ucm213559.htm, "PROVENGE® (Sipuleucel T, APC8015) is an autologous cellular immunotherapy product consisting of peripheral blood mononuclear cells (PBMCs) obtained from patients by leukapheresis and activated in vitro with a recombinant fusion protein (prostatic acid phosphatase fused with GM-CSF)…FDA will require the sponsor to complete a post marketing study to evaluate the risk of stroke in patients who receive sipuleucel-T."

Provenge® has FDA approved labeling for the treatment of asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer.

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