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{{update|date=December 2015}}
{{Use dmy dates|date=April 2020}}
{{Drugbox {{Drugbox
| Verifiedfields = changed
| type = vaccine
| Watchedfields = changed
| image =
| verifiedrevid = 423050273
| alt =
| drug_name =
| width =
| image2 = | type =
| alt2 = | image =
| width =
| width2 =
| alt =
| imagename = <!-- else may use drug_name -->
| caption =
| drug_name = Sipuleucel-T
| target = prostate cancer
| vaccine_type = protein subunit
| CAS_number = 917381-47-6
| CAS_supplemental =
| ATCvet =
| ATC_prefix = L
| ATC_suffix = 03
| ATC_supplemental = AX
| PubChem =
| PubChemSubstance = 85151648
| IUPHAR_ligand =
| DrugBank =
| ChemSpiderID =
| UNII =
| KEGG = D06644
| ChEBI =
| ChEMBL =
| licence_EU = <!-- EMA requires brand name -->
| licence_US = <!-- FDA may use generic name -->
| DailyMedID = <!-- preference to licence_US -->
| pregnancy_AU = <!-- A / B1 / B2 / B3 / C / D / X -->
| pregnancy_US = <!-- A / B / C / D / X -->
| pregnancy_category=
| legal_AU = <!-- S2, S3, S4, S5, S6, S7, S8, S9 or Unscheduled-->
| legal_CA = <!-- OTC, Rx-only, Schedule I, II, III, IV, V, VI, VII, VIII -->
| legal_UK = <!-- GSL, P, POM, CD, CD Lic, CD POM, CD No Reg POM, CD (Benz) POM, CD (Anab) POM or CD Inv POM -->
| legal_US = <!-- OTC / Rx-only / Schedule I, II, III, IV, V -->
| legal_status =
| dependency_liability =
| routes_of_administration = ]
}}


<!-- Clinical data -->
'''Sipuleucel-T''' (APC8015, Provenge),<ref name="Plosker_2011"/><ref name = ""US6210662"/> manufactured by ] Corporation, is a patient specific ] ] for ] (CaP). A ''therapeutic'' vaccine is designed to treat the active disease. A ''preventive'' vaccine is to cure the condition (usually a virus) causing the cancer. As of 2011 there are two approved ] cancer ''prevention'' vaccines. These are for the cancer causing viruses ] and ].
| tradename = Provenge
| Drugs.com = {{drugs.com|cons|sipuleucel-t-intravenous}}
| MedlinePlus = a611025
| licence_EU = <!-- EMA requires brand name -->
| DailyMedID = Sipuleucel-T
| pregnancy_AU = <!-- A / B1 / B2 / B3 / C / D / X -->
| pregnancy_category = N/A (only approved in men, prostate cancer)
| dependency_liability =
| routes_of_administration = ]
| ATCvet =
| ATC_prefix = L03
| ATC_suffix = AX17
| ATC_supplemental =


<!-- Legal status -->
== Cancer Immunotherapeutic history ==
| legal_AU = <!-- S2, S3, S4, S5, S6, S7, S8, S9 or Unscheduled -->
Sipuleucel-T is the first therapeutic cancer vaccine to demonstrate effectiveness in Phase III ]s by prolonging the life of patients who have advanced to the late stage of the disease, ], asymptomatic, ] (HRPC). Other names for this stage are metastatic Castrate-Resistant (mCRPC) and Androgen Independent (AI) or (AIPC). This stage leads to mCRPC with lymph node involement and distal (distant) tumors, this is the lethal stage of CaP. The ] designation is T4,N1,M1c.<ref name="Kantoff"/><ref name="Small"/><ref name="Longo"/> Its approach to elicit an immune response against cancer cells results in a novel and uniquely effective treatment that "could extend the life of prostate cancer patients with far fewer of the harsh side effects of traditional treatments such as surgery, radiation and chemotherapy."<ref name="revolutionary"/><ref name="breakthrough"/><ref name="oncologystat1"/>
| legal_AU_comment =
| legal_BR = <!-- OTC, A1, A2, A3, B1, B2, C1, C2, C3, C4, C5, D1, D2, E, F -->
| legal_BR_comment =
| legal_CA = <!-- OTC, Rx-only, Schedule I, II, III, IV, V, VI, VII, VIII -->
| legal_CA_comment =
| legal_DE = <!-- Anlage I, II, III or Unscheduled -->
| legal_DE_comment =
| legal_NZ = <!-- Class A, B, C -->
| legal_NZ_comment =
| legal_UK = <!-- GSL, P, POM, CD, CD Lic, CD POM, CD No Reg POM, CD (Benz) POM, CD (Anab) POM or CD Inv POM / Class A, B, C -->
| legal_UK_comment =
| legal_US = Rx-only
| legal_US_comment = <ref name="Provenge FDA label">{{cite web | title=Provenge- sipuleucel-t injection | website=DailyMed | url=https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8309b497-5d4e-4408-ac0c-2452c11c8a35 | access-date=22 July 2021}}</ref><ref name="FDA Provenge" />
| legal_EU =
| legal_EU_comment =
| legal_UN = <!-- N I, II, III, IV / P I, II, III, IV -->
| legal_UN_comment =
| legal_status = <!-- For countries not listed above -->


<!-- Identifiers -->
== First FDA approved cancer vaccine ==
| CAS_number_Ref = {{cascite|correct|??}}
| CAS_number = 917381-47-6
| CAS_supplemental =
| IUPHAR_ligand =
| DrugBank_Ref = {{drugbankcite|changed|drugbank}}
| DrugBank = DB06688
| ChemSpiderID_Ref =
| ChemSpiderID = None
| UNII_Ref = {{fdacite|changed|FDA}}
| UNII = 8Q622VDR18
| KEGG_Ref = {{keggcite|correct|kegg}}
| KEGG = D06644
| ChEBI_Ref =
| ChEBI =
| ChEMBL_Ref = {{ebicite|changed|EBI}}
| ChEMBL = 1237024
| synonyms = APC8015


<!-- Chemical data -->
Sipuleucel-T was approved by the U.S. ] (FDA) on April 29, 2010 to treat asymptomatic or minimally symptomatic metastatic HRPC.<ref name="Reuters approved"/><ref name= "FDA approval letter"/>
}}


'''Sipuleucel-T''', sold under the brand name '''Provenge''', developed by ] Pharmaceuticals, LLC, is a cell-based ] for ] (CaP).<ref name="Provenge FDA label" /><ref name="Plosker_2011"/><ref name="US6210662"/> It is an autologous cellular immunotherapy.<ref name="Provenge FDA label" />
Shortly afterward, Sipuleucel-T was added to the Compendium of cancer treatments published by the ] (NCCN) as a "category 1" (highest recommendation) treatment for HRPC. The NCCN Compendium is a source sanctioned by Medicare and used by major healthcare insurance providers to decide whether and when a treatment should be covered when a physician recommends it for established indications.<ref name = "provenge-nccn"/><ref name="about-nccn"/>


== Treatment method == == Medical uses ==
Sipuleucel-T is indicated for the treatment of ], asymptomatic or minimally symptomatic, metastatic castrate-resistant ] (HRPC). Other names for this stage are metastatic castrate-resistant (mCRPC) and androgen independent (AI) or (AIPC). This stage leads to mCRPC with lymph node involvement and distal (distant) tumors; this is the lethal stage of CaP. The ] designation is T4,N1,M1c.<ref name="Kantoff"/><ref name="Small"/><ref name="Longo"/>


=== Treatment method ===
A course of Sipuleucel-T treatment consists of three basic steps:


A course of treatment consists of three basic steps:
# A patient's own white blood cells, primarily ] (APCs), also called Dendritic cells, are extracted in a ] procedure.
* The patient's white blood cells, primarily ]s, a type of ] (APCs), are extracted in a ] procedure.
# The blood product is sent to the factory and incubated with a fusion protein (PA2024) consisting of two parts,
* The blood product is sent to a production facility and incubated with a fusion protein (PA2024) consisting of two parts:
##the antigen ] (PAP), which is present in 95% of prostate cancer cells, and
** The ] ] (PAP), which is present in 95% of prostate cancer cells and
##an immune signaling factor ] (GM-CSF) that helps the APCs to mature.
** An immune signaling factor ] (GM-CSF) that helps the APCs to mature.
#The activated blood product (APC8015) is returned from the factory to the infusion center and re-infused into the patient to cause an immune response against cancer cells carrying the PAP antigen.<ref name="Kantoff"/><ref name="Small"/>
* The activated blood product (APC8015) is returned from the production facility to the infusion center and reinfused into the patient.<ref name="Kantoff" /><ref name="Small" />


Premedication with acetaminophen and antihistamine is recommended to minimize side effects.<ref name="pmid20818862">{{cite journal | vauthors = Kantoff PW, Higano CS, Shore ND, Berger ER, Small EJ, Penson DF, Redfern CH, Ferrari AC, Dreicer R, Sims RB, Xu Y, Frohlich MW, Schellhammer PF | display-authors = 6 | title = Sipuleucel-T immunotherapy for castration-resistant prostate cancer | journal = The New England Journal of Medicine | volume = 363 | issue = 5 | pages = 411–22 | date = July 2010 | pmid = 20818862 | doi = 10.1056/NEJMoa1001294 | doi-access = free }} </ref>
A complete Sipuleucel-T treatment repeats three courses over the span of a month, with two weeks between successive courses.<ref name="pmid16752945"/>


==Survival benefit== ==Side effects==
Common side effects include: bladder pain; bloating or swelling of the face, arms, hands, lower legs, or feet; bloody or cloudy urine; body aches or pain; chest pain; chills; confusion; cough; diarrhea; difficult, burning, or painful urination; difficulty with breathing; difficulty with speaking up to inability to speak; double vision; sleeplessness; and inability to move the arms, legs, or facial muscles.<ref name="MayoClinic1">{{cite web|url=https://www.mayoclinic.org/drugs-supplements/sipuleucel-t-intravenous-route/side-effects/drg-20074285|title=Sipuleucel-T (Intravenous Route) - Side Effects |publisher=Mayo Clinic|access-date=22 April 2015}}</ref><ref name="FDA1">{{cite web|url=https://www.fda.gov/downloads/BiologicsBloodVaccines/CellularGeneTherapyProducts/ApprovedProducts/UCM210031.pdf|title=Package Insert and Patient Information - Provenge (PDF - 157KB)|publisher=] (FDA)|access-date=22 April 2015}}</ref>


== Society and culture ==
Sipuleucel-T showed "] (OS)" benefit to patients in three double-blind randomized ], D9901,<ref name="Small"/> D9902a,<ref name="Higano"/><ref name = "ECCO"/> and IMPACT.<ref name="Kantoff"/>
=== Legal status ===
Sipuleucel-T was approved by the U.S. ] (FDA) on April 29, 2010, to treat asymptomatic or minimally symptomatic metastatic HRPC.<ref name="Reuters approved"/><ref name= "FDA approval letter"/><ref name="FDA Provenge">{{cite web | title=Provenge (sipuleucel-T) | website=U.S. Food and Drug Administration | date=22 July 2017 | url=https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/provenge-sipuleucel-t | access-date=1 April 2020}}</ref><ref>{{cite web | title=Provenge (sipuleucel-T) | website=U.S. Food and Drug Administration | date=14 July 2017 | url=https://www.fda.gov/BiologicsBloodVaccines/CellularGeneTherapyProducts/ApprovedProducts/ucm210012.htm | archive-url=https://wayback.archive-it.org/7993/20170722071307/https://www.fda.gov/BiologicsBloodVaccines/CellularGeneTherapyProducts/ApprovedProducts/ucm210012.htm | url-status=unfit | archive-date=2017-07-22 | access-date=1 April 2020}}</ref><ref name="Provenge FDA label" />


Shortly afterward, sipuleucel-T was added to the compendium of cancer treatments published by the ] (NCCN) as a "category 1" (highest recommendation) treatment for HRPC. The NCCN Compendium is used by Medicare and major health care insurance providers to decide whether a treatment should be reimbursed.<ref name = "provenge-nccn"/><ref name="about-nccn"/>
The D9901 trial<ref name="Small"/> enrolled 127 patients with asymptomatic metastatic HRPC randomized in a 2:1 ratio. The median survival time for patients treated with Sipuleucel-T was 25.9 months comparing to 21.4 months for placebo-treated patients. Overall survival was ] with ] 0.01, i.e., the chance of the result being a false positive was less than one percent.


== Research ==
The D9902a trial<ref name="Higano"/> was designed like the D9901 trial but it enrolled only 98 patients. The median survival time for patients treated with Sipuleucel-T was 19.0 months comparing to 15.3 months for placebo-treated patients. Overall survival did not achieve statistical significance but did show a trend in improving survival as seen in the difference between treated and placebo median survival times.
===Clinical trials===


==== Completed ====
The IMPACT trial<ref name="Kantoff"/> served as the basis for licensing approval of Sipuleucel-T by the FDA. This trial enrolled 512 patients with asymptomatic or minimally symptomatic metastatic HRPC randomized in a 2:1 ratio.
Sipuleucel-T showed ] (OS) benefit to patients in three double-blind randomized ], D9901,<ref name="Small"/> D9902a,<ref name="Higano"/><ref name = "ECCO"/> and IMPACT.<ref name="Kantoff"/>
The median survival time for Sipuleucel-T patients was 25.8 months comparing to 21.7 months for placebo-treated patients. Overall survival was ] with ] 0.032.


The IMPACT trial<ref name="Kantoff"/> served as the basis for FDA licensing. This trial enrolled 512 patients with asymptomatic or minimally symptomatic metastatic HRPC randomized in a 2:1 ratio. The median survival time for sipuleucel-T patients was 25.8 months comparing to 21.7 months for placebo-treated patients, an increase of 4.1 months.<ref>{{cite book|vauthors=Lacroix M|title=Targeted Therapies in Cancer|date=2014|publisher=Nova Sciences Publishers|location=Hauppauge, NY|isbn=978-1-63321-687-7|url=https://www.novapublishers.com/catalog/product_info.php?products_id=50994|access-date=20 July 2014|archive-date=26 June 2015|archive-url=https://web.archive.org/web/20150626172243/https://www.novapublishers.com/catalog/product_info.php?products_id=50994|url-status=dead}}</ref> 31.7% of treated patients survived for 36 months vs. 23.0% in the control arm.<ref>{{cite journal | vauthors = Kantoff PW, Higano CS, Shore ND, Berger ER, Small EJ, Penson DF, Redfern CH, Ferrari AC, Dreicer R, Sims RB, Xu Y, Frohlich MW, Schellhammer PF | display-authors = 6 | title = Sipuleucel-T immunotherapy for castration-resistant prostate cancer | journal = The New England Journal of Medicine | volume = 363 | issue = 5 | pages = 411–22 | date = July 2010 | pmid = 20818862 | doi = 10.1056/NEJMoa1001294 | doi-access = free }}</ref> Overall survival was ] (P=0.032). The longer survival without tumor shrinkage or change in progression is surprising. This may suggest the effect of an unmeasured variable.<ref name="Longo"/> The trial was conducted pursuant to a FDA Special Protocol Assessment (SPA), a set of guidelines binding trial investigators to specific agreed-upon parameters with respect to trial design, procedures and endpoints; compliance ensured overall scientific integrity and accelerated FDA approval.{{citation needed|date=April 2015}}
Placebo patients in all three trials were allowed to cross over after disease progression to take a version of Sipuleucel-T made from their frozen blood saved on trial entry (APC8015F). The publication of the IMPACT study<ref name="Kantoff"/> observed that the cross-over patients had an estimated median survival time of 23.8 months comparing to 11.6 months for those patients who never received Sipuleucel-T in any form. However, this observation was retrospective so a prospective test would be required before the implied benefit of frozen Sipuleucel-T could be confirmed.


The D9901 trial<ref name="Small"/> enrolled 127 patients with asymptomatic metastatic HRPC randomized in a 2:1 ratio. The median survival time for patients treated with sipuleucel-T was 25.9 months comparing to 21.4 months for placebo-treated patients. Overall survival was ] (]).{{cn|date=May 2021}}
==Side effects==


The D9902a trial<ref name="Higano"/> was designed like the D9901 trial but enrolled 98 patients. The median survival time for patients treated with sipuleucel-T was 19.0 months comparing to 15.3 months for placebo-treated patients, but did not reach statistical significance.{{cn|date=May 2021}}
The side effects of Sipuleucel-T were mostly limited to chills, fever, fatigue, nausea and headache which usually occurred within the first few days of treatment. In addition, more serious ] were observed at a rate
of 2.4% in patients treated with Sipuleucel-T vs 1.8% in placebo-treated patients.<ref name="Kantoff"/>


==== Ongoing ====
== Additional clinical trials ==
As of August 2014, the PRO Treatment and Early Cancer Treatment (PROTECT) trial, a phase IIIB clinical trial started in 2001, was tracking subjects but no longer enrolling new subjects.<ref name="NCT00779402" /> Its purpose is to test efficacy for patients whose CaP is still controlled by either suppression of ] by hormone treatment or by ]. Such patients have usually failed primary treatment of either surgical removal of the prostate, (]), internal radiation, ] or (]) for curative intent. Such failure is called biochemical failure and is defined as a PSA reading of 2.0&nbsp;ng/mL above nadir (the lowest reading taken post primary treatment).<ref name="Roach_2006" />


As of August 2014, a clinical trial administering sipuleucel-T in conjunction with ] (Yervoy) was tracking subjects but no longer enrolling new subjects; the trial evaluates the clinical safety and anti-cancer effects (quantified in PSA, radiographic and T cell response) of the combination therapy in patients with advanced prostate cancer.<ref name="sip-T-ipi-trial" />
*PROTECT '''PRO''' '''T'''reatment and '''E'''arly '''C'''ancer '''T'''reatment a phase IIIB clinical trial started October, 2008 and is currently underway.<ref name="NCT00779402"/> Its purpose is to test efficacy for patients whose CaP is still controlled by either, ] or ]. Such patients have usually failed primary treatment of either surgical removal of the prostate, (]), internal radiation, ] or (]) for curative intent. Such failure is called biochemical failure and refers to a PSA reading of 2.0 ng/mL above nadir (the lowest reading taken post primary treatment).<ref name="Roach_2006"/>

*NEOACT ('''NEO'''adjuvant '''A'''ctive '''C'''ellular '''I'''mmuno'''T'''herapy) a phase II initially a single-site trial in men with localized CaP scheduled for ].<ref name="NCT00715104"/> The sites are UCSF in ], ca, USC/Norris Comprehensive Cancer Center, ], ca., Oregon, Health and Science University, ], Kaiser Permenante, Portland, Oregon, University of Utah, School of Medicine, ] and Virgina Mason Medical Center, ].

*ProACT ('''PRO'''state cancer '''A'''ctive '''C'''ellular Immuno'''T'''herapy) a phase II multicenter metastatic androgen independent CaP. Testing three different strengths of the PA2024 antigen used to fuse the PAP and GM-CSF.<ref name="NCT00715078"/>

== Cost of treatment ==
The total cost for three courses of treatment with Sipuleucel-T is $93,000.<ref name="Longo"/> The NEJM review<ref name="Longo"/> has contrasted that cost against an average cost figure of $1,800 per patient per month.<ref name="Alemayehu_2010"/> However, as a large number of patients surveyed in the study chose not to be treated with any treatment to avoid side effects,<ref name="Miller"/> the cost estimate was not suitable to compare with a treatment with survival benefit such as Sipuleucel-T. An in-depth analysis of cost per additional month of ''median survival advantage''<ref name="Miller"/> showed that the cost of Sipuleucel-T was similar to that of ], the standard of care for HRPC before Sipuleucel-T was approved for marketing.


== References == == References ==
{{Reflist | colwidth=30em | refs = {{Reflist | refs =


<ref name="Plosker_2011">{{cite journal | author = Plosker GL | title = Sipuleucel-T: in metastatic castration-resistant prostate cancer | journal = Drugs | volume = 71 | issue = 1 | pages = 101–8 | year = 2011 | month = January | pmid = 21175243 | doi = 10.2165/11206840-000000000-00000 | url = | issn = }}</ref> <ref name="Plosker_2011">{{cite journal | vauthors = Plosker GL | title = Sipuleucel-T: in metastatic castration-resistant prostate cancer | journal = Drugs | volume = 71 | issue = 1 | pages = 101–8 | date = January 2011 | pmid = 21175243 | doi = 10.2165/11206840-000000000-00000 | s2cid = 209171318 }}</ref>


<ref name = ""US6210662">{{ cite patent | country = US | number = 6210662 | status = granted | title = Immunostimulatory composition | pubdate = 2001-04-03 | gdate = | fdate = 1999-06-24 | pridate = | inventor = Laus R, Ruegg CL, Wu H | assign1 = Dendreon Corporation (Seattle, WA) | class = }}</ref> <ref name="US6210662">{{US patent|6210662|Immunostimulatory composition}}</ref>


<ref name="Kantoff">{{cite journal | author = Kantoff PW, Higano CS, Shore ND, Berger ER, Small EJ, Penson DF, Redfern CH, Ferrari AC, Dreicer R, Sims RB, Xu Y, Frohlich MW, Schellhammer PF | title = Sipuleucel-T immunotherapy for castration-resistant prostate cancer | journal = N. Engl. J. Med. | volume = 363 | issue = 5 | pages = 411–22 | year = 2010 | month = July | pmid = 20818862 | doi = 10.1056/NEJMoa1001294 | url = | issn = }}</ref> <ref name="Kantoff">{{cite journal | vauthors = Kantoff PW, Higano CS, Shore ND, Berger ER, Small EJ, Penson DF, Redfern CH, Ferrari AC, Dreicer R, Sims RB, Xu Y, Frohlich MW, Schellhammer PF | display-authors = 6 | title = Sipuleucel-T immunotherapy for castration-resistant prostate cancer | journal = The New England Journal of Medicine | volume = 363 | issue = 5 | pages = 411–22 | date = July 2010 | pmid = 20818862 | doi = 10.1056/NEJMoa1001294 | doi-access = free }}</ref>


<ref name="Small">{{cite journal | author = Small EJ, Schellhammer PF, Higano CS, Redfern CH, Nemunaitis JJ, Valone FH, Verjee SS, Jones LA, Hershberg RM | title = Placebo-controlled phase III trial of immunologic therapy with sipuleucel-T (APC8015) in patients with metastatic, asymptomatic hormone refractory prostate cancer | journal = J. Clin. Oncol. | volume = 24 | issue = 19 | pages = 3089–94 | year = 2006 | month = July | pmid = 16809734 | doi = 10.1200/JCO.2005.04.5252 | url = | issn = }}</ref> <ref name="Small">{{cite journal | vauthors = Small EJ, Schellhammer PF, Higano CS, Redfern CH, Nemunaitis JJ, Valone FH, Verjee SS, Jones LA, Hershberg RM | display-authors = 6 | title = Placebo-controlled phase III trial of immunologic therapy with sipuleucel-T (APC8015) in patients with metastatic, asymptomatic hormone refractory prostate cancer | journal = Journal of Clinical Oncology | volume = 24 | issue = 19 | pages = 3089–94 | date = July 2006 | pmid = 16809734 | doi = 10.1200/JCO.2005.04.5252 | doi-access = free }}</ref>


<ref name="pmid16752945">{{cite journal | author = | title = Sipuleucel-T: APC 8015, APC-8015, prostate cancer vaccine--Dendreon | journal = Drugs R D | volume = 7 | issue = 3 | pages = 197–201 | year = 2006 | pmid = 16752945 | doi = | url = | issn = }}</ref> <ref name="Longo">{{cite journal | vauthors = Longo DL | title = New therapies for castration-resistant prostate cancer | journal = The New England Journal of Medicine | volume = 363 | issue = 5 | pages = 479–81 | date = July 2010 | pmid = 20818868 | doi = 10.1056/NEJMe1006300 }}</ref>


<ref name="Longo">{{cite journal | author = Longo DL | title = New therapies for castration-resistant prostate cancer | journal = N. Engl. J. Med. | volume = 363 | issue = 5 | pages = 479–81 | year = 2010 | month = July | pmid = 20818868 | doi = 10.1056/NEJMe1006300 | url = | issn = }}</ref> <ref name="Reuters approved">{{cite news | title=U.S. FDA OKs Dendreon's prostate cancer vaccine | author = Richwine L | work = Reuters| date = 2010-04-29 | url = https://www.reuters.com/article/idUSN2919838820100429 | access-date = 2010-04-30 }}</ref>


<ref name= "FDA approval letter">{{cite web |url=https://www.fda.gov/BiologicsBloodVaccines/CellularGeneTherapyProducts/ApprovedProducts/ucm210215.htm | title=Approval Letter - Provenge | publisher=] | date=2010-04-29 }}</ref>
<ref name="revolutionary">{{ cite news | author = Clarke S, Childs D | title = Provenge Uses Body's Immune System to Fight Prostate Cancer | publisher = ABC News | date = 2010-04-26 | url = http://abcnews.go.com/GMA/OnCall/prostate-cancer-vaccine-fda-approve-provenge-week/story?id=10473544}} </ref>


<ref name="provenge-nccn">{{cite web | url = http://www.nccn.org/about/news/international_ebulletin/2010-07-26/guidelines_compendium.asp | title = NCCN Guidelines and NCCN Compendium Updated | access-date = 2011-01-08}}</ref>
<ref name="breakthrough">{{ cite news | author = Perrone M | title = FDA approves breakthrough cancer therapy Provenge | agency=AP News|date=April 29, 2010| url = http://www.newsmeat.com/news/meat.php?articleId=74605695&channelId=2951&buyerId=newsmeatcom&buid=3281}} </ref>


<ref name="about-nccn">{{cite web | url = http://www.nccn.org/professionals/drug_compendium/content/contents.asp | title = NCCN Drugs & Biologics Compendium }}</ref>
<ref name="oncologystat1">{{ cite news | title = Survival Benefit of Sipuleucel-T in Prostate Cancer Appears Durable | publisher= Elsevier Global Medical News | date = 2010-03-11 | url = http://www.oncologystat.com/news/Survival_Benefit_of_Sipuleucel-T_in_Prostate_Cancer_Appears_Durable_US.html}} </ref>


<ref name="Higano">{{cite conference |vauthors=Higano C, Burch P, Small E, Schellhammer P, Lemon R, Verjee S, Hershberg R | title = Immunotherapy (APC8015) for androgen independent prostate cancer (AIPC): final progression and survival data from a second Phase 3 trial | conference = 13th European Cancer Conference | location = Paris |date=October 2005 }}</ref>
<ref name="Reuters approved">{{cite news | title=U.S. FDA OKs Dendreon's prostate cancer vaccine | author = Richwine L | agency = Reuters| date = 2010-04-29 | url = http://www.reuters.com/article/idUSN2919838820100429 | accessdate = 2010-04-30 }}</ref>


<ref name= "FDA approval letter">{{cite web |url=http://www.fda.gov/BiologicsBloodVaccines/CellularGeneTherapyProducts/ApprovedProducts/ucm210215.htm | title=Approval Letter - Provenge | publisher=] | date=2010-04-29 }}</ref> <ref name = "ECCO" >{{cite news | url = http://www.eurekalert.org/pub_releases/2005-11/foec-nto110205.php | author = Mason K | agency = ECCO-the European CanCer Organisation | date = 2005-11-02 | title = New treatment options for patients with prostate cancer}}</ref>


<ref name="Roach_2006">{{cite journal | vauthors = Roach M, Hanks G, Thames H, Schellhammer P, Shipley WU, Sokol GH, Sandler H | title = Defining biochemical failure following radiotherapy with or without hormonal therapy in men with clinically localized prostate cancer: recommendations of the RTOG-ASTRO Phoenix Consensus Conference | journal = International Journal of Radiation Oncology, Biology, Physics | volume = 65 | issue = 4 | pages = 965–74 | date = July 2006 | pmid = 16798415 | doi = 10.1016/j.ijrobp.2006.04.029 }}</ref>
<ref name="provenge-nccn">{{cite web | url = http://www.nccn.org/about/news/international_ebulletin/2010-07-26/guidelines_compendium.asp | title = NCCN Guidelines™ and NCCN Compendium™ Updated | author = | authorlink = | coauthors = | date = | format = | work = | publisher = | pages = | language = | archiveurl = | archivedate = | quote = | accessdate = 2011-01-08}}</ref>


<ref name="about-nccn">{{cite web | url = http://www.nccn.org/professionals/drug_compendium/content/contents.asp | title = NCCN Drugs & Biologics Compendium™ | author = | authorlink = | coauthors = | date = | format = | work = | publisher = | pages = | language = | archiveurl = | archivedate = | quote = | accessdate = }}</ref> <ref name="NCT00779402">{{cite journal | url = http://clinicaltrials.gov/ct2/show/NCT00779402 | title = NCT00779402: Provenge for the Treatment of Hormone Sensitive Prostate Cancer | journal = ClinicalTrials.gov | date = 29 June 2017 | publisher = US National Institutes of Health }}</ref>


<ref name="sip-T-ipi-trial">{{cite journal | url=http://clinicaltrials.gov/ct2/show/NCT01832870?term=sipipi&rank=1 | title=Sipuleucel-T and ipilimumab clinical trials | journal = ClinicalTrials.gov | date=23 August 2017 | publisher = US National Institutes of Health}}</ref>
<ref name="Higano">{{cite conference | author = Higano C, Burch P, Small E, Schellhammer P, Lemon R, Verjee S, Hershberg R | title = Immunotherapy (APC8015) for androgen independent prostate cancer (AIPC): final progression and survival data from a second Phase 3 trial | conference = 13th European Cancer Conference | location = Paris | year = 2005 | month = October }} </ref>
}}
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== Further reading ==
<ref name = "ECCO" >{{cite news | url = http://www.eurekalert.org/pub_releases/2005-11/foec-nto110205.php | author = Mason K | agency = ECCO-the European CanCer Organisation | date = 2005-11-02 | title = New treatment options for patients with prostate cancer}} </ref>
* {{cite journal | vauthors=Huber ML, Haynes L, Parker C, Iversen P | title = Interdisciplinary critique of sipuleucel-T as immunotherapy in castration-resistant prostate cancer | journal = Journal of the National Cancer Institute | volume = 104 | issue = 4 | pages = 273–9 |date=February 2012 | doi = 10.1093/jnci/djr514 | pmid = 22232132 | pmc = 3283534 }}

<ref name="Roach_2006">{{cite journal | author = Roach M, Hanks G, Thames H, Schellhammer P, Shipley WU, Sokol GH, Sandler H | title = Defining biochemical failure following radiotherapy with or without hormonal therapy in men with clinically localized prostate cancer: recommendations of the RTOG-ASTRO Phoenix Consensus Conference | journal = Int. J. Radiat. Oncol. Biol. Phys. | volume = 65 | issue = 4 | pages = 965–74 | year = 2006 | month = July | pmid = 16798415 | doi = 10.1016/j.ijrobp.2006.04.029 | url = | issn = }}</ref> * {{cite journal | vauthors = | title = Sipuleucel-T: APC 8015, APC-8015, prostate cancer vaccine--Dendreon | journal = Drugs in R&D | volume = 7 | issue = 3 | pages = 197–201 | year = 2006 | pmid = 16752945 | doi = 10.2165/00126839-200607030-00006 | s2cid = 6427074 }}

<ref name="NCT00779402">{{cite web | url = http://clinicaltrials.gov/ct2/show/NCT00779402 | title = NCT00779402: Provenge for the Treatment of Hormone Sensitive Prostate Cancer | author = | authorlink = | coauthors = | date = | format = | work = ClinicalTrials.gov | publisher = US National Institutes of Health | pages = | language = | archiveurl = | archivedate = | quote = | accessdate = }}</ref>

<ref name="NCT00715104">{{cite web | url = http://clinicaltrials.gov/ct2/show/NCT00715104?term=NEOACT&rank=1 | title = NCT00715104: Sipuleucel-T as Neoadjuvant Treatment in Prostate Cancer | author = | authorlink = | coauthors = | date = | format = | work = ClinicalTrials.gov | publisher = US National Institutes of Health | pages = | language = | archiveurl = | archivedate = | quote = | accessdate = }}</ref>

<ref name="NCT00715078">{{cite web | url = http://clinicaltrials.gov/ct2/show/NCT00715078?term=PROACT&rank=2 | title = NCT00715078: To Evaluate Sipuleucel-T Manufactured With Different Concentrations of PA2024 Antigen | author = | authorlink = | coauthors = | date = | format = | work = ClinicalTrials.gov | publisher = US National Institutes of Health | pages = | language = | archiveurl = | archivedate = | quote = | accessdate = }}</ref>

<ref name="Alemayehu_2010">{{cite journal | author = Alemayehu B, Buysman E, Parry D, Becker L, Nathan F | title = Economic burden and healthcare utilization associated with castration-resistant prostate cancer in a commercial and Medicare Advantage US patient population | journal = J Med Econ | volume = 13 | issue = 2 | pages = 351–61 | year = 2010 | month = June | pmid = 20491610 | doi = 10.3111/13696998.2010.491435 | url = | issn = }}</ref>

<ref name="Miller">{{ cite web| author = Miller D | date = July 29, 2010 | accessdate = 2010-08-27 | title = Dendreon's Provenge Costs the Same as Chemotherapy | url = http://www.minyanville.com/businessmarkets/articles/dendreon-provenge-cost-taxotere-sanofi-aventis/7/29/2010/id/29371}} </ref>

}}


== External links == == External links ==
* {{cite web | url = https://druginfo.nlm.nih.gov/drugportal/name/sipuleucel-t | publisher = U.S. National Library of Medicine | work = Drug Information Portal | title = Sipuleucel-T }}
* {{cite web | url = http://www.provenge.com | title = Provenge (sipuleucel T) &#124; Advanced Prostate Cancer &#124; | author = | authorlink = | coauthors = | date = | format = | work = Provenge.com | publisher = Dendreon Corporation | pages = | language = | archiveurl = | archivedate = | quote = | accessdate = }}
* {{cite web | url = http://www.dendreon.com/ | title = Dendreon | author = | authorlink = | coauthors = | date = | format = | work = Dendreon.com | publisher = Dendreon Corporation | pages = | language = | archiveurl = | archivedate = | quote = | accessdate = }}

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