Sipuleucel-T

Identification

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Name
Sipuleucel-T
Accession Number
DB06688
Type
Biotech
Groups
Approved, Investigational
Biologic Classification
Cell transplant therapies
Autologous cell transplant
Description

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.

Synonyms
  • Sipuleucel-T
External IDs
APC 8015 / APC8015
Prescription Products
NameDosageStrengthRouteLabellerMarketing StartMarketing End
ProvengeInjection50000000 1/1IntravenousDendreon Pharmaceuticals Llc2010-04-29Not applicableUs
Additional Data Available
  • Application Number
    Application Number

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  • Product Code
    Product Code

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Categories
UNII
8Q622VDR18
CAS number
917381-47-6

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.

Associated Conditions
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
Additional Data Available
Adverse Effects

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Contraindications

Structured data covering drug contraindications. Each contraindication describes a scenario in which the drug is not to be used. Includes restrictions on co-administration, contraindicated populations, and more.

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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
Toxicity
Not Available
Affected organisms
  • Humans and other mammals
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
2-MethoxyethanolThe therapeutic efficacy of Sipuleucel-T can be decreased when used in combination with 2-Methoxyethanol.
9-(N-methyl-L-isoleucine)-cyclosporin AThe therapeutic efficacy of Sipuleucel-T can be decreased when used in combination with 9-(N-methyl-L-isoleucine)-cyclosporin A.
AbataceptThe therapeutic efficacy of Sipuleucel-T can be decreased when used in combination with Abatacept.
AbetimusThe therapeutic efficacy of Sipuleucel-T can be decreased when used in combination with Abetimus.
ActeosideThe therapeutic efficacy of Sipuleucel-T can be decreased when used in combination with Acteoside.
AdalimumabThe therapeutic efficacy of Sipuleucel-T can be decreased when used in combination with Adalimumab.
AfelimomabThe therapeutic efficacy of Sipuleucel-T can be decreased when used in combination with Afelimomab.
AldesleukinThe therapeutic efficacy of Sipuleucel-T can be decreased when used in combination with Aldesleukin.
AldosteroneThe therapeutic efficacy of Sipuleucel-T can be decreased when used in combination with Aldosterone.
AlefaceptThe therapeutic efficacy of Sipuleucel-T can be decreased when used in combination with Alefacept.
Additional Data Available
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    Extended Description

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    Severity

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    Action

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Food Interactions
Not Available

References

General References
  1. Authors unspecified: Sipuleucel-T: APC 8015, APC-8015, prostate cancer vaccine--Dendreon. Drugs R D. 2006;7(3):197-201. [PubMed:16752945]
  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. [PubMed:26025563]
  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. [PubMed:15176049]
  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. [PubMed:16736512]
  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. [PubMed:21572775]
External Links
KEGG Drug
D06644
PubChem Substance
347910360
ChEMBL
CHEMBL1237024
RxList
RxList Drug Page
Drugs.com
Drugs.com Drug Page
PDRhealth
PDRhealth Drug Page
Wikipedia
Sipuleucel-T
ATC Codes
L03AX17 — Sipuleucel-t
FDA label
Download (157 KB)

Clinical Trials

Clinical Trials
PhaseStatusPurposeConditionsCount
1Active Not RecruitingTreatmentMetastatic Hormone Refractory Prostate Cancer1
1CompletedOtherProstate Cancer1
1CompletedTreatmentCastrate Resistant Prostate Cancer (CRPC) / Prostate Cancer1
2Active Not RecruitingTreatmentMCRPC / Metastatic Castrate-Resistant Prostate Cancer1
2Active Not RecruitingTreatmentMetastatic Hormone Refractory Prostate Cancer1
2Active Not RecruitingTreatmentProstate Cancer3
2CompletedNot AvailableProstate Cancer / Prostate Neoplasms / Prostatic Neoplasms1
2CompletedBasic ScienceCastration-Resistant Prostate Cancer (CRPC) / Hormone Refractory Prostate Cancer / Metastatic Hormone Refractory Prostate Cancer1
2CompletedBasic ScienceMetastatic Hormone Refractory Prostate Cancer1
2CompletedTreatmentAdenocarcinoma of the Prostate / Bone Metastases / Hormone-Resistant Prostate Cancer / Recurrent Prostate Cancer / Soft Tissue Metastases / Stage IV Prostate Cancer1
2CompletedTreatmentHormone-Resistant Prostate Cancer / Metastatic Hormone Refractory Prostate Cancer / Recurrent Prostate Carcinoma / Stage IV Prostate Cancer1
2CompletedTreatmentProstate Cancer5
2CompletedTreatmentProstate Cancer / Prostatic Adenocarcinoma / Prostatic Neoplasms1
2WithdrawnTreatmentProstate Cancer2
3Active Not RecruitingBasic ScienceAdenocarcinoma of the Prostate1
3CompletedTreatmentHormone-Refractory Prostate Cancer1
3CompletedTreatmentProstate Cancer3
Not AvailableCompletedNot AvailableAdvanced Prostate Cancer / Prostatic Neoplasms1
Not AvailableCompletedNot AvailableCastrate Refractory Metastatic Prostate Cancer (mCRPC)1
Not AvailableCompletedNot AvailableProstate Cancer1
Not AvailableTerminatedNot AvailableProstate Cancer1

Pharmacoeconomics

Manufacturers
Not Available
Packagers
Not Available
Dosage forms
FormRouteStrength
InjectionIntravenous50000000 1/1
Prices
Not Available
Patents
Patent NumberPediatric ExtensionApprovedExpires (estimated)
US8153120No2012-04-102027-03-22Us
Additional Data Available
  • Filed On
    Filed On

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Properties

State
Not Available
Experimental Properties
Not Available

Taxonomy

Classification
Not classified

Targets

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. [PubMed:15176049]
  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. [PubMed:16736512]
  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. [PubMed:26025563]

Drug created on March 19, 2008 10:49 / Updated on December 02, 2019 07:26