Identification

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
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. The precise mechanism remains unknown, however.

TargetActionsOrganism
UProstatic acid phosphatase
antagonist
inhibitory immune response
Human
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
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.
AlclometasoneThe therapeutic efficacy of Sipuleucel-T can be decreased when used in combination with Alclometasone.
AldesleukinThe therapeutic efficacy of Sipuleucel-T can be decreased when used in combination with Aldesleukin.
AlemtuzumabThe therapeutic efficacy of Sipuleucel-T can be decreased when used in combination with Alemtuzumab.
AmcinonideThe therapeutic efficacy of Sipuleucel-T can be decreased when used in combination with Amcinonide.
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).
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]
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 RecruitingOtherProstate Cancer1
1CompletedTreatmentCastrate Resistant Prostate Cancer (CRPC) / Prostate Cancer1
1RecruitingTreatmentMetastatic Hormone Refractory Prostate Cancer1
2Active Not RecruitingBasic ScienceHormone Refractory Prostate Cancer / Metastatic Hormone Refractory Prostate Cancer1
2Active Not RecruitingBasic ScienceMetastatic Hormone Refractory Prostate Cancer1
2Active Not RecruitingTreatmentAdenocarcinoma of the Prostate / Bone Metastases / Hormone-Resistant Prostate Cancer / Recurrent Prostate Cancer / Soft Tissue Metastases / Stage IV Prostate Cancer1
2Active Not RecruitingTreatmentMetastatic Hormone Refractory Prostate Cancer1
2Active Not RecruitingTreatmentProstate Cancer1
2CompletedNot AvailableCancer of the Prostate / Prostate Cancer / Prostate Neoplasms / Prostatic Neoplasms1
2CompletedTreatmentHormone-Resistant Prostate Cancer / Metastatic Hormone Refractory Prostate Cancer / Recurrent Prostate Carcinoma / Stage IV Prostate Cancer1
2CompletedTreatmentProstate Cancer4
2CompletedTreatmentProstate Cancer / Prostatic Adenocarcinoma / Prostatic Neoplasms1
2RecruitingTreatmentMCRPC / Metastatic Castrate-Resistant Prostate Cancer1
2RecruitingTreatmentProstate Cancer2
2WithdrawnTreatmentProstate Cancer2
3CompletedTreatmentHormone-Refractory Prostate Cancer1
3CompletedTreatmentProstate Cancer3
Not AvailableActive Not RecruitingNot AvailableAdvanced Prostate Cancer / Prostatic Neoplasms1
Not AvailableActive Not RecruitingNot AvailableCastrate Refractory Metastatic Prostate Cancer (mCRPC)1
Not AvailableRecruitingNot AvailableProstate Cancer2

Pharmacoeconomics

Manufacturers
Not Available
Packagers
Not Available
Dosage forms
FormRouteStrength
InjectionIntravenous50000000 1/1
Prices
Not Available
Patents
Patent NumberPediatric ExtensionApprovedExpires (estimated)
US8153120No2007-03-222027-03-22Us

Properties

State
Not Available
Experimental Properties
Not Available

Taxonomy

Classification
Not classified

Targets

Kind
Protein
Organism
Human
Pharmacological action
Unknown
Actions
Antagonist
Inhibitory immune response
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 August 02, 2018 05:38