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{{Short description|Cancer drug}}
{{Drugbox
{{cs1 config|name-list-style=vanc|display-authors=6}}
{{more science citations needed|date=November 2016}}
{{Use dmy dates|date=March 2020}}
{{Infobox drug
| Verifiedfields = changed
| verifiedrevid = 443693471
| type = combo | type = combo

<!-- Combo data -->
| component1 = Paclitaxel | component1 = Paclitaxel
| class1 = ] | class1 = ]
| component2 = Albumin | component2 = Albumin
| class2 = delivery vehicle | class2 = Delivery vehicle


<!--Clinical data--> <!-- Clinical data -->
| tradename = Abraxane | tradename = Abraxane, others
| Drugs.com = | Drugs.com = {{drugs.com|monograph|paclitaxel}}
| MedlinePlus = | MedlinePlus = a619008
| DailyMedID = Paclitaxel
| pregnancy_AU = <!-- A / B1 / B2 / B3 / C / D / X -->
⚫ | pregnancy_AU = D
| pregnancy_US = <!-- A / B / C / D / X -->
| pregnancy_category= | pregnancy_category=
⚫ | routes_of_administration = ]
| legal_AU = <!-- S2, S3, S4, S5, S6, S7, S8, S9 or Unscheduled-->
⚫ | ATC_prefix = L01
| legal_CA = <!-- OTC, Rx-only, Schedule I, II, III, IV, V, VI, VII, VIII -->
⚫ | ATC_suffix = CD01
| 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_AU = S4
| legal_CA = Rx-only
| legal_CA_comment = <ref>{{cite web | title=Product monograph brand safety updates | website=] | date=7 July 2016 | url=https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database/label-safety-assessment-update/product-monograph-brand-safety-updates.html | access-date=3 April 2024}}</ref>
| legal_UK = POM
| legal_US = Rx-only | legal_US = Rx-only
| legal_EU = Rx-only
⚫ | legal_status =
| legal_status = Rx-only
⚫ | routes_of_administration = IV


<!--Identifiers--> <!-- Identifiers -->
| ChemSpiderID_Ref = {{chemspidercite|changed|chemspider}}
⚫ | CAS_number =
| ATCvet = | ChemSpiderID = none
| CAS_number_Ref = {{cascite|correct|CAS}}
| ATC_prefix = <!-- 'none' if uncategorised -->
| ATC_suffix = | CAS_number = 33069-62-4
| UNII_Ref = {{fdacite|correct|FDA}}
| UNII = P88XT4IS4D
| PubChem = | PubChem =
| DrugBank_Ref = {{drugbankcite|correct|drugbank}}
⚫ | DrugBank =
| DrugBank = DB01229
| KEGG = D00491
}} }}


'''Protein-bound paclitaxel''' is an ] formulation of ], a ] ] used in the treatment of ].<ref>{{Cite web|url= http://www.cancer.gov/Templates/db_alpha.aspx?CdrID=507751 |title= Definition of "protein-bound paclitaxel" |publisher= ] Dictionary of Cancer Terms }}</ref> In this formulation, paclitaxel is bonded to ] as a delivery vehicle. It is sold in the ] under the trade name Abraxane by Abraxis Bioscience.<ref>{{Cite web|url= http://www.cancer.gov/cancertopics/druginfo/nanoparticlepaclitaxel |title= Paclitaxel Albumin-stabilized Nanoparticle Formulation |publisher= ] Drug Information }}</ref> '''Protein-bound paclitaxel''', also known as '''] albumin–bound paclitaxel''' or '''nab-paclitaxel''', is an ] formulation of ] used to treat ], ] and ], among others. Paclitaxel kills cancer cells by preventing the normal breakdown of ]s during cell division.<ref>{{Cite web|url= http://www.cancer.gov/dictionary?CdrID=507751 |title= Definition of "protein-bound paclitaxel" |publisher= ] Dictionary of Cancer Terms |date= 2011-02-02|df=mdy-all }}</ref><ref name=reuters12 /><ref name=nytimes13 /> In this formulation, paclitaxel is bonded to ] as a delivery vehicle.<ref>{{Cite web|url= http://www.cancer.gov/cancertopics/druginfo/nanoparticlepaclitaxel |title= Paclitaxel Albumin-stabilized Nanoparticle Formulation |publisher= ] Drug Information |year= 2006 }}</ref> It is manufactured and sold in the ] by ] under the trade name '''Abraxane''' where it is designated as an ] as first-line treatment, in combination with ], for the ] "metastatic adenocarcinoma of the pancreas".<ref name="orphanet_2013">{{cite web |url=http://www.orpha.net/consor/cgi-bin/Drugs_Search.php?lng=EN&data_id=101438&search=Drugs_Search_Simple&data_type=Status&Typ=Med |website=Orpha Net |date=September 6, 2013 |access-date=July 20, 2015 |title=Abraxane}}</ref>


This treatment was approved in the United States in 2005,<ref>{{Cite magazine| vauthors = Knapp A |date=August 27, 2020|title=The Inside Story Of Biotech's Barnum And His Covid Cures|url=https://www.forbes.com/sites/alexknapp/2020/08/27/the-inside-story-of-biotechs-barnum-and-his-covid-cures/|access-date=2020-08-27|magazine=Forbes|language=en}}</ref> and the European Union in 2008, for ] cases where cancer did not respond to other ] or has relapsed.<ref>{{Cite web|url= http://www.cancer.gov/cancertopics/druginfo/fda-nanoparticle-paclitaxel |title= FDA Approval for Nanoparticle Paclitaxel |publisher= ] Drug Information |year= 2006 }}</ref><ref>{{cite web | title=Abraxane EPAR | website=] (EMA) | date=9 March 2020 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/abraxane | access-date=9 March 2020}}</ref> In 2012, the FDA widened the approved uses to include treatment for NSCLC.<ref name=reuters12>{{Cite news|url= https://www.reuters.com/article/us-celgene-abraxane-idUSBRE89B0SQ20121012|df=mdy-all |title=FDA approves Celgene's Abraxane for lung cancer |newspaper=Reuters |date=2012-10-12 }}</ref><ref>{{cite web|url= https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm323668.htm|title=Paclitaxel (Abraxane)|publisher=U.S. ]|date=October 11, 2012|access-date=10 December 2012}}</ref> In 2013, the FDA approved protein-bound paclitaxel for use in treating advanced ] as a less toxic (although less effective) alternative to ].<ref name=nytimes13>{{cite news | vauthors = Pollack A |title=F.D.A. Approves a Drug for Late-Stage Pancreatic Cancer |newspaper=] |date=September 7, 2013 |url=https://www.nytimes.com/2013/09/07/business/fda-approves-drug-for-late-stage-pancreatic-cancer.html |access-date=September 6, 2013}}</ref>
This treatment was approved by the ] in January 2005 for ] cases where cancer did not respond to other ] or has relapsed.<ref>{{Cite web|url= http://www.cancer.gov/cancertopics/druginfo/fda-nanoparticle-paclitaxel |title= FDA Approval for Nanoparticle Paclitaxel |publisher= ] Drug Information }}</ref>


==Society and culture==
Abraxane is a first in its class of drugs using nanoparticle albumin bound (nab) technology platform.<ref></ref>
Abraxane is registered on the Australian Register of Therapeutic Goods for the treatment of metastatic carcinoma of the breast after failure of ] therapy.<ref>{{cite web|title=Resolution 9190|newspaper=Therapeutic Goods Administration (Tga)|url=http://www.tga.gov.au/archive/committees-adec-resolutions-0258.htm |date=June 6, 2008}}</ref> Abraxane is also included on the Schedule of the Australian ] although<ref>{{cite journal | vauthors = Vines T, Faunce T | title = Assessing the safety and cost-effectiveness of early nanodrugs | journal = Journal of Law and Medicine | volume = 16 | issue = 5 | pages = 822–845 | date = May 2009 | pmid = 19554862 }}</ref> the manufacturer was unable to convince the independent ] that the drug warranted a higher price than existing comparator drugs.<ref>{{cite web|url=http://www.health.gov.au/internet/main/publishing.nsf/Content/pbac-psd-paclitaxel-nov08|title=PBAC, Public Summary Document|date=November 2008|website=health.gov.au}}</ref> Protein-bound paclitaxel was developed by VivoRx which became ] as the first in its class of drugs to use the nanoparticle albumin bound (nab) technology platform.<ref>{{cite web|url=http://www.abraxisbio.com/rnd_platform_nab.htm|title=Celgene: A Global Biopharmaceutical Company Committed to Improving the Lives of Patients Worldwide with Innovative and Life-Changing Treatments|website=www.abraxisbio.com}}</ref>


In June 2010, positive results were published from a phase III trial in first-line ] (NSCLC) when compared with ] (solvent-based paclitaxel).<ref name=A201006>{{Cite web|url=http://www.genengnews.com/gen-news-highlights/abraxis-reports-phase-iii-success-with-abraxane-in-first-line-nsclc/81243495/ |title=Abraxis Reports Phase III Success with Abraxane in First-Line NSCLC |year=2010 }}</ref> In 2010, Abraxis was acquired by ], which now markets Abraxane.<ref>{{cite press release|url=http://ir.celgene.com/phoenix.zhtml?c=111960&p=irol-newsArticle&ID=1483257&highlight=|title=Celgene Completes Acquisition of Abraxis|website=Celgene}}</ref> Total revenue from the sales of Abraxane for 2009 were $314.5 million.<ref name=A201006>{{Cite web|url=http://www.genengnews.com/gen-news-highlights/abraxis-reports-phase-iii-success-with-abraxane-in-first-line-nsclc/81243495/ |title=Abraxis Reports Phase III Success with Abraxane in First-Line NSCLC |year=2010|website=www.genengnews.com/ }}</ref> In 2013, Abraxane was FDA approved for the treatment of pancreatic cancer.<ref>{{cite press release|website=FDA|url=https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm367442.htm|title=FDA approves Abraxane for late-stage pancreatic cancer}}</ref> In 2014, Abraxane's sales were $848 million, 31 percent year-over-year increase.<ref>{{cite press release|website=Celgene|url=http://ir.celgene.com/releasedetail.cfm?releaseid=890827|title=Celgene Corporation Announces 2015 and Long-Term Financial Outlook and Preliminary 2014 Results (NASDAQ:CELG)}}</ref>


The UK's ] (NICE) announced in 2015, that it would not support the routine use of protein-bound paclitaxel in advanced pancreatic cancer on the NHS.<ref>{{cite web|url=http://www.pancreaticcancer.org.uk/latest-news/2015/september/last-hope-dashed-for-access-to-life-extending-pancreatic-cancer-drug-on-the-nhs-in-england/#sthash.PpHk2Lur.dpuf|title=NHS England stop access to Abraxane - Pancreatic Cancer UK|date=September 2015|website=www.pancreaticcancer.org.uk/}}</ref> However, this decision was changed in September 2017.<ref>{{Cite web |date=2017-09-06 |title=Overview {{!}} Paclitaxel as albumin-bound nanoparticles with gemcitabine for untreated metastatic pancreatic cancer {{!}} Guidance {{!}} NICE |url=https://www.nice.org.uk/guidance/ta476 |access-date=2024-12-26 |website=www.nice.org.uk}}</ref> It has continued to be reimbursed in England since then, despite questionable real world effectiveness.<ref>{{cite journal | vauthors = Wadd N, Peedell C, Polwart C | title = Real-World Assessment of Cancer Drugs Using Local Data Uploaded to the Systemic Anti-Cancer Therapy Dataset in England | journal = Clinical Oncology | volume = 34 | issue = 8 | pages = 497–507 | date = August 2022 | pmid = 35584974 | doi = 10.1016/j.clon.2022.04.012 }}</ref>
Total revenue from the sales of Abraxane for 2009 were $314.5 million.<ref name=A201006/>


⚫ == References ==
In 2010, Abraxis was acquired by Celgene, who now market Abraxane.<ref></ref>

⚫ ==References==
{{Reflist}} {{Reflist}}


== Further reading ==
{{refbegin}}
* {{cite journal | vauthors = Miele E, Spinelli GP, Miele E, Tomao F, Tomao S | title = Albumin-bound formulation of paclitaxel (Abraxane ABI-007) in the treatment of breast cancer | journal = International Journal of Nanomedicine | volume = 4 | pages = 99–105 | year = 2009 | pmid = 19516888 | pmc = 2720743 | doi = 10.2147/ijn.s3061 | doi-access = free }}
* {{cite journal | vauthors = Stinchcombe TE | title = Nanoparticle albumin-bound paclitaxel: a novel Cremphor-EL-free formulation of paclitaxel | journal = Nanomedicine | volume = 2 | issue = 4 | pages = 415–423 | date = August 2007 | pmid = 17716129 | doi = 10.2217/17435889.2.4.415 }}
* {{cite journal | vauthors = Gradishar WJ | title = Albumin-bound paclitaxel: a next-generation taxane | journal = Expert Opinion on Pharmacotherapy | volume = 7 | issue = 8 | pages = 1041–1053 | date = June 2006 | pmid = 16722814 | doi = 10.1517/14656566.7.8.1041 | s2cid = 12736839 }}
{{refend}}


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