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.
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Indication Type Indication Combined Product Details Approval Level Age Group Patient Characteristics Dose Form Treatment of Asymptomatic, metastatic hormone-refractory prostate cancer •••••••••••• Treatment of Minimally symptomatic, metastatic hormone-refractory prostate cancer •••••••••••• - Contraindications & Blackbox Warnings
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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.
Target Actions Organism AProstatic acid phosphatase otherHumans - 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
- Improve decision support & research outcomesWith structured adverse effects data, including: blackbox warnings, adverse reactions, warning & precautions, & incidence rates. View sample adverse effects data in our new Data Library!Improve decision support & research outcomes with our structured adverse effects data.
- 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.
Drug Interaction Integrate drug-drug
interactions in your softwareAbatacept The therapeutic efficacy of Sipuleucel-T can be decreased when used in combination with Abatacept. Adalimumab The therapeutic efficacy of Sipuleucel-T can be decreased when used in combination with Adalimumab. Aldesleukin The therapeutic efficacy of Sipuleucel-T can be decreased when used in combination with Aldesleukin. Alefacept The therapeutic efficacy of Sipuleucel-T can be decreased when used in combination with Alefacept. Alemtuzumab The therapeutic efficacy of Sipuleucel-T can be decreased when used in combination with Alemtuzumab. - Food Interactions
- No interactions found.
Products
- Drug product information from 10+ global regionsOur datasets provide approved product information including:dosage, form, labeller, route of administration, and marketing period.Access drug product information from over 10 global regions.
- Brand Name Prescription Products
Name Dosage Strength Route Labeller Marketing Start Marketing End Region Image Provenge Injection 50000000 1/1 Intravenous Dendreon Pharmaceuticals Llc 2010-04-29 Not applicable US
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
- Authors unspecified: Sipuleucel-T: APC 8015, APC-8015, prostate cancer vaccine--Dendreon. Drugs R D. 2006;7(3):197-201. [Article]
- 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]
- 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]
- 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]
- 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]
- External Links
- KEGG Drug
- D06644
- PubChem Substance
- 347910360
- 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
Phase Status Purpose Conditions Count 3 Active Not Recruiting Treatment Adenocarcinoma of Prostate 1 3 Completed Treatment Hormone-Refractory Prostate Cancer 1 3 Completed Treatment Prostate Cancer 3 3 Not Yet Recruiting Treatment Metastatic Castration-Resistant Prostate Cancer (mCRPC) 1 2 Completed Not Available Neoplasms of the Prostate / Prostate Cancer 1
Pharmacoeconomics
- Manufacturers
- Not Available
- Packagers
- Not Available
- Dosage Forms
Form Route Strength Injection Intravenous 50000000 1/1 - Prices
- Not Available
- Patents
Patent Number Pediatric Extension Approved Expires (estimated) Region US8153120 No 2012-04-10 2027-03-22 US
Properties
- State
- Not Available
- Experimental Properties
- Not Available
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
- 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]
- 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]
- 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 at March 19, 2008 16:49 / Updated at April 30, 2021 13:06