Sipuleucel-T (Provenge)

General information

Class/mechanism: Autologous cellular immunotherapy, with each dose containing a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF. Autologous peripheral blood mononuclear cells, which include antigen presenting cells (APCs), are obtained via leukapheresis. They are then activated in vitro with prostatic acid phosphatase (PAP), an antigen expressed in prostate cancer tissue, linked to granulocyte-macrophage colony-stimulating factor (GM-CSF), and reinfused into the patient. The reinfused cells are then hypothesized to mediate immune reactions against prostate cancer cells.
Route: IV
Extravasation: no information

For conciseness and simplicity, HemOnc.org currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. Instead, for the most current information, please refer to your preferred pharmacopeias such as Micromedex, Lexicomp, UpToDate (courtesy of Lexicomp), or the prescribing information.

Diseases for which it is used

• Prostate cancer

Patient drug information

• Sipuleucel-T (Provenge) package insert
• Sipuleucel-T (Provenge) patient drug information (Chemocare)
• Sipuleucel-T (Provenge) patient drug information (UpToDate)

History of changes in FDA indication

• 2010-04-29: Initial FDA approval for the treatment of asymptomatic or minimally symptomatic metastatic castrate-resistant (hormone-refractory) prostate cancer. (Based on D9901 and IMPACT_prostate)

History of changes in EMA indication

• 2013-09-06: Initial authorization for treating men with asymptomatic or minimally symptomatic metastatic (non-visceral) castrate-resistant prostate cancer in whom chemotherapy is not yet clinically indicated.
• 2015-05-06: Authorization withdrawn at the request of the manufacturer, for commercial reasons

Also known as

• Code name: APC-8015
• Brand name: Provenge