Sipuleucel-T

Identification

Summary

Sipuleucel-T is an autologous cellular immunotherapy indicated for the treatment of asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer.

Brand Names
Provenge
Generic Name
Sipuleucel-T
DrugBank Accession Number
DB06688
Background

Sipuleucel-T is a personalized, autologous, cellular immunotherapy. Sipuleucel-T is a therapeutic cancer vaccine for prostate cancer. Sipuleucel-T selectively targets the prostate-specific antigen (PSA) known as prostatic acid phosphatase (PAP) that is expressed in around 95% of prostate cancers. It must be prepared specifically for each patient. In metastatic prostate cancer, it has extended survival by median 4.1 months (IMPACT Phase III trial data). Sipuleucel-T is marketed under the brand name Provenge by Dendreon Corporation. Sipuleucel-T was approved by the U.S. Food and Drug Administration (FDA) on April 29, 2010, to treat asymptomatic or minimally symptomatic metastatic Hormone-Refractory Prostate Cancer (HRPC). The treatment initially cost $93,000 at the time of FDA approval, but rose to over $100,000 in 2014.

Type
Biotech
Groups
Approved, Investigational
Biologic Classification
Cell transplant therapies
Autologous cell transplant
Synonyms
  • Sipuleucel-T
External IDs
  • APC 8015
  • APC8015

Pharmacology

Indication

Sipuleucel-T is an autologous cellular immunotherapy indicated for the treatment of asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer.

Pharmacology
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Associated Conditions
Contraindications & Blackbox Warnings
Contraindications
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Pharmacodynamics

Not Available

Mechanism of action

Sipuleucel-T is designed to induce an immune response targeted against PAP, an antigen expressed in most prostate cancers. During ex vivo culture with PAP-GM-CSF, APCs take up and process the recombinant target antigen into small peptides that are then displayed on the APC surface. This process is done indirectly by the activation of T-cells against PAP which is upregulated by the metastatic cancer cells.5 The precise mechanism remains unknown, however.

TargetActionsOrganism
AProstatic acid phosphatase
other
Humans
Absorption

Not Available

Volume of distribution

Not Available

Protein binding

Not Available

Metabolism
Not Available
Route of elimination

Not Available

Half-life

Not Available

Clearance

Not Available

Adverse Effects
Adverseeffects
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Toxicity

Not Available

Pathways
Not Available
Pharmacogenomic Effects/ADRs
Not Available

Interactions

Drug Interactions
This information should not be interpreted without the help of a healthcare provider. If you believe you are experiencing an interaction, contact a healthcare provider immediately. The absence of an interaction does not necessarily mean no interactions exist.
DrugInteraction
AbataceptThe therapeutic efficacy of Sipuleucel-T can be decreased when used in combination with Abatacept.
AdalimumabThe therapeutic efficacy of Sipuleucel-T can be decreased when used in combination with Adalimumab.
AldesleukinThe therapeutic efficacy of Sipuleucel-T can be decreased when used in combination with Aldesleukin.
AlefaceptThe therapeutic efficacy of Sipuleucel-T can be decreased when used in combination with Alefacept.
AlemtuzumabThe therapeutic efficacy of Sipuleucel-T can be decreased when used in combination with Alemtuzumab.
AltretamineThe therapeutic efficacy of Sipuleucel-T can be decreased when used in combination with Altretamine.
AmsacrineThe therapeutic efficacy of Sipuleucel-T can be decreased when used in combination with Amsacrine.
AnakinraThe therapeutic efficacy of Sipuleucel-T can be decreased when used in combination with Anakinra.
Antilymphocyte immunoglobulin (horse)The therapeutic efficacy of Sipuleucel-T can be decreased when used in combination with Antilymphocyte immunoglobulin (horse).
Antithymocyte immunoglobulin (rabbit)The therapeutic efficacy of Sipuleucel-T can be decreased when used in combination with Antithymocyte immunoglobulin (rabbit).
Interactions
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Food Interactions
No interactions found.

Products

Products2
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Brand Name Prescription Products
NameDosageStrengthRouteLabellerMarketing StartMarketing EndRegionImage
ProvengeInjection50000000 1/1IntravenousDendreon Pharmaceuticals Llc2010-04-29Not applicableUS flag

Categories

ATC Codes
L03AX17 — Sipuleucel-t
Drug Categories
Classification
Not classified
Affected organisms
  • Humans and other mammals

Chemical Identifiers

UNII
8Q622VDR18
CAS number
917381-47-6

References

General References
  1. Authors unspecified: Sipuleucel-T: APC 8015, APC-8015, prostate cancer vaccine--Dendreon. Drugs R D. 2006;7(3):197-201. [Article]
  2. Mulders PF, De Santis M, Powles T, Fizazi K: Targeted treatment of metastatic castration-resistant prostate cancer with sipuleucel-T immunotherapy. Cancer Immunol Immunother. 2015 Jun;64(6):655-63. doi: 10.1007/s00262-015-1707-3. Epub 2015 May 30. [Article]
  3. Burch PA, Croghan GA, Gastineau DA, Jones LA, Kaur JS, Kylstra JW, Richardson RL, Valone FH, Vuk-Pavlovic S: Immunotherapy (APC8015, Provenge) targeting prostatic acid phosphatase can induce durable remission of metastatic androgen-independent prostate cancer: a Phase 2 trial. Prostate. 2004 Aug 1;60(3):197-204. [Article]
  4. Rini BI, Weinberg V, Fong L, Conry S, Hershberg RM, Small EJ: Combination immunotherapy with prostatic acid phosphatase pulsed antigen-presenting cells (provenge) plus bevacizumab in patients with serologic progression of prostate cancer after definitive local therapy. Cancer. 2006 Jul 1;107(1):67-74. [Article]
  5. Anassi E, Ndefo UA: Sipuleucel-T (provenge) injection: the first immunotherapy agent (vaccine) for hormone-refractory prostate cancer. P T. 2011 Apr;36(4):197-202. [Article]
KEGG Drug
D06644
PubChem Substance
347910360
RxNav
997261
ChEMBL
CHEMBL1237024
RxList
RxList Drug Page
Drugs.com
Drugs.com Drug Page
PDRhealth
PDRhealth Drug Page
Wikipedia
Sipuleucel-T
FDA label
Download (157 KB)

Clinical Trials

Clinical Trials
PhaseStatusPurposeConditionsCount
3Active Not RecruitingTreatmentAdenocarcinoma of the Prostate1
3CompletedTreatmentHormone Refractory Prostate Cancer1
3CompletedTreatmentProstate Cancer3
2Active Not RecruitingTreatmentMCRPC / Metastatic Castration Resistant Prostate Cancer (CRPC)1
2CompletedNot AvailableNeoplasms of the Prostate / Prostate Cancer / Prostatic Neoplasms1
2CompletedBasic ScienceCastration Resistant Prostate Cancer / Hormone Refractory Prostate Cancer / Refractory, metastatic hormone-refractory Prostate cancer1
2CompletedBasic ScienceRefractory, metastatic hormone-refractory Prostate cancer1
2CompletedTreatmentAdenocarcinoma of the Prostate / Bone Metastases / Hormone Resistant Prostate Cancer / Prostate Cancer - Recurrent / Soft Tissue Metastases / Stage IV Prostate Cancer1
2CompletedTreatmentHormone Resistant Prostate Cancer / Recurrent Prostate Carcinoma / Refractory, metastatic hormone-refractory Prostate cancer / Stage IV Prostate Cancer1
2CompletedTreatmentProstate Cancer7

Pharmacoeconomics

Manufacturers
Not Available
Packagers
Not Available
Dosage Forms
FormRouteStrength
InjectionIntravenous50000000 1/1
Prices
Not Available
Patents
Patent NumberPediatric ExtensionApprovedExpires (estimated)Region
US8153120No2012-04-102027-03-22US flag

Properties

State
Not Available
Experimental Properties
Not Available

Targets

Drugtargets2
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Kind
Protein
Organism
Humans
Pharmacological action
Yes
Actions
Other
General Function
Thiamine phosphate phosphatase activity
Specific Function
A non-specific tyrosine phosphatase that dephosphorylates a diverse number of substrates under acidic conditions (pH 4-6) including alkyl, aryl, and acyl orthophosphate monoesters and phosphorylate...
Gene Name
ACPP
Uniprot ID
P15309
Uniprot Name
Prostatic acid phosphatase
Molecular Weight
44565.715 Da
References
  1. Burch PA, Croghan GA, Gastineau DA, Jones LA, Kaur JS, Kylstra JW, Richardson RL, Valone FH, Vuk-Pavlovic S: Immunotherapy (APC8015, Provenge) targeting prostatic acid phosphatase can induce durable remission of metastatic androgen-independent prostate cancer: a Phase 2 trial. Prostate. 2004 Aug 1;60(3):197-204. [Article]
  2. Rini BI, Weinberg V, Fong L, Conry S, Hershberg RM, Small EJ: Combination immunotherapy with prostatic acid phosphatase pulsed antigen-presenting cells (provenge) plus bevacizumab in patients with serologic progression of prostate cancer after definitive local therapy. Cancer. 2006 Jul 1;107(1):67-74. [Article]
  3. Mulders PF, De Santis M, Powles T, Fizazi K: Targeted treatment of metastatic castration-resistant prostate cancer with sipuleucel-T immunotherapy. Cancer Immunol Immunother. 2015 Jun;64(6):655-63. doi: 10.1007/s00262-015-1707-3. Epub 2015 May 30. [Article]

Drug created on March 19, 2008 16:49 / Updated on April 30, 2021 13:06