:Protein-bound paclitaxel

{{Infobox drug

| Verifiedfields = changed

| verifiedrevid = 443693471

| type = combo

| component1 = Paclitaxel

| class1 = Mitotic inhibitor

| component2 = Albumin

| class2 = Delivery vehicle

| tradename = Abraxane, others

| Drugs.com = {{drugs.com|monograph|paclitaxel}}

| MedlinePlus = a619008

| DailyMedID = Paclitaxel

| pregnancy_AU = D

| pregnancy_category=

| routes_of_administration = Intravenous

| ATC_prefix = L01

| ATC_suffix = CD01

| legal_AU = S4

| legal_CA = Rx-only

| legal_CA_comment = {{cite web | title=Product monograph brand safety updates | website=Health Canada | 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}}

| legal_UK = POM

| legal_US = Rx-only

| legal_EU = Rx-only

| legal_status = Rx-only

| ChemSpiderID_Ref = {{chemspidercite|changed|chemspider}}

| ChemSpiderID = none

| CAS_number_Ref = {{cascite|correct|CAS}}

| CAS_number = 33069-62-4

| UNII_Ref = {{fdacite|correct|FDA}}

| UNII = P88XT4IS4D

| PubChem =

| DrugBank_Ref = {{drugbankcite|correct|drugbank}}

| DrugBank = DB01229

| KEGG = D00491

}}

Protein-bound paclitaxel, also known as nanoparticle albumin–bound paclitaxel or nab-paclitaxel, is an injectable formulation of paclitaxel used to treat breast cancer, lung cancer and pancreatic cancer, among others. Paclitaxel kills cancer cells by preventing the normal breakdown of microtubules during cell division.{{Cite web|url= http://www.cancer.gov/dictionary?CdrID=507751 |title= Definition of "protein-bound paclitaxel" |publisher= National Cancer Institute Dictionary of Cancer Terms |date= 2011-02-02|df=mdy-all }}{{Cite web |title=Nab-paclitaxel (Abraxane) |url=https://www.cancerresearchuk.org/about-cancer/treatment/drugs/nab-paclitaxel |access-date=2025-04-13 |website=www.cancerresearchuk.org |language=en}} In this formulation, paclitaxel is bonded to albumin as a delivery vehicle.{{Cite web|url= http://www.cancer.gov/cancertopics/druginfo/nanoparticlepaclitaxel |title= Paclitaxel Albumin-stabilized Nanoparticle Formulation |publisher= National Cancer Institute Drug Information |year= 2006 }} It is manufactured and sold in the United States by Celgene under the trade name Abraxane where it is designated as an orphan drug as first-line treatment, in combination with gemcitabine, for the orphan disease "metastatic adenocarcinoma of the pancreas".{{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}}

This treatment was approved in the United States in 2005,{{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}} and the European Union in 2008, for breast cancer cases where cancer did not respond to other chemotherapy or has relapsed.{{Cite web|url= http://www.cancer.gov/cancertopics/druginfo/fda-nanoparticle-paclitaxel |title= FDA Approval for Nanoparticle Paclitaxel |publisher= National Cancer Institute Drug Information |year= 2006 }}{{cite web | title=Abraxane EPAR | website=European Medicines Agency (EMA) | date=9 March 2020 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/abraxane | access-date=9 March 2020}} In 2012, the FDA widened the approved uses to include treatment for NSCLC.{{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 }}{{cite web|url= https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm323668.htm|title=Paclitaxel (Abraxane)|publisher=U.S. Food and Drug Administration|date=October 11, 2012|access-date=10 December 2012}} In 2013, the FDA approved protein-bound paclitaxel for use in treating advanced pancreatic cancer as a less toxic (although less effective) alternative to FOLFIRINOX.{{cite news | vauthors = Pollack A |title=F.D.A. Approves a Drug for Late-Stage Pancreatic Cancer |newspaper=New York Times |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}}

Society and culture

Abraxane is registered on the Australian Register of Therapeutic Goods for the treatment of metastatic carcinoma of the breast after failure of anthracycline therapy.{{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}} Abraxane is also included on the Schedule of the Australian Pharmaceutical Benefits Scheme although{{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 }} the manufacturer was unable to convince the independent Pharmaceutical Benefits Advisory Committee that the drug warranted a higher price than existing comparator drugs.{{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}} Protein-bound paclitaxel was developed by VivoRx which became Abraxis BioScience as the first in its class of drugs to use the nanoparticle albumin bound (nab) technology platform.{{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}}

In 2010, Abraxis was acquired by Celgene, which now markets Abraxane.{{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}} Total revenue from the sales of Abraxane for 2009 were $314.5 million.{{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/ }} In 2013, Abraxane was FDA approved for the treatment of pancreatic cancer.{{cite press release|website=FDA|url=https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm367442.htm|title=FDA approves Abraxane for late-stage pancreatic cancer}} In 2014, Abraxane's sales were $848 million, 31 percent year-over-year increase.{{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)}} In 2019 Bristol Meyers Squibb acquired Celgene for $74 billion dollars, and thus acquired Abraxis Bioscience and the rights to manufacture and market Abraxane.{{cite web | last=Kansteiner | first=Fraiser | title=Bristol Myers' subsidiary behind cancer blockbuster Abraxane slapped with FDA warning letter | website=Fierce Pharma | date=2022-11-09 | url=https://www.fiercepharma.com/manufacturing/bristol-myers-subsidiary-behind-cancer-blockbuster-abraxane-slapped-fda-warning | access-date=2025-03-12}}

The UK's National Institute for Health and Care Excellence (NICE) announced in 2015, that it would not support the routine use of protein-bound paclitaxel in advanced pancreatic cancer on the NHS.{{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/}} However, this decision was changed in September 2017.{{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}} It has continued to be reimbursed in England since then, despite questionable real world effectiveness.{{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 }}

:Protein-bound paclitaxel

Society and culture

References

Further reading