Abstract
Abstract Sipuleucel-T is an FDA approved autologous cellular immunotherapy indicated for the treatment of asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer. It consists of autologous peripheral blood mononuclear cells, including antigen presenting cells (APCs), which have been activated during a defined culture period with a recombinant human protein, PAP-GM-CSF, consisting of prostatic acid phosphatase (PAP), an antigen expressed in prostate cancer tissue, linked to granulocyte-macrophage colony stimulating factor (GM-CSF), an immune cell activator. The development history will be summarized; the regulatory milestones will be described; and the lessons learned during the development of this novel approach to the treatment of prostate cancer will be discussed. Citation Format: {Authors}. {Abstract title} [abstract]. In: Proceedings of the AACR-NCI-EORTC International Conference: Molecular Targets and Cancer Therapeutics; 2011 Nov 12-16; San Francisco, CA. Philadelphia (PA): AACR; Mol Cancer Ther 2011;10(11 Suppl):Abstract nr PL04-01.
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