Sipuleucel-T is an autologous cellular immunotherapy designed to induce an immune response targeted against prostatic acid phosphatase (PAP), an antigen expressed in most prostate cancers. Peripheral blood mononuclear cells collected from the patients are cultured with PAP-GM-CSF, a fusion protein consisting of PAP linked to granulocyte-macrophage colony-stimulating factor (GM-CSF) an immune cell activator. During ex vivo culture with PAP-GM-CSF, activated APCs (antigen presenting cells) take up and process the recombinant target antigen into peptides that are then presented to T cells.
This medicinal substance has been classified in the anatomical therapeutic chemical (ATC) classification according to its main therapeutic use as follows:
| ATC code | Group title | Classification |
|---|---|---|
| L03AX17 | Sipuleucel-T | L Antineoplastic and immunomodulating agents → L03 Immunostimulants → L03A Immunostimulants → L03AX Other immunostimulants |
Competent medicine agencies globally have authorized commercialization of this active ingredient according to these medication package inserts (MPIs):
| Title | Information Source | Document Type | |
|---|---|---|---|
| PROVENGE Dispersion for infusion | European Medicines Agency (EU) | MPI, EU: SmPC |
Sipuleucel-T is an active ingredient of these brands:
Estonia (EE)Note the following: The list of brand names is continuously updated, and thus does not include the total of products circulating worldwide. |
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