Chemistry:Protein-bound paclitaxel

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Short description: Cancer drug
Protein-bound paclitaxel
Combination of
PaclitaxelMitotic inhibitor
AlbuminDelivery vehicle
Clinical data
Trade namesAbraxane, others
AHFS/Drugs.comMonograph
MedlinePlusa619008
License data
Pregnancy
category
  • AU: D
  • US: N (Not classified yet)
Routes of
administration		Intravenous (IV)
ATC code
Legal status
Legal status
  • AU: S4 (Prescription only)
  • UK: POM (Prescription only)
  • US: ℞-only
  • EU: Rx-only
  • In general: ℞ (Prescription only)
Identifiers
CAS Number
DrugBank
ChemSpider
  • none
UNII
KEGG
 ☒N☑Y (what is this?)  (verify)

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.[1][2][3] In this formulation, paclitaxel is bonded to albumin as a delivery vehicle.[4] 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".[5]

This treatment was approved in the United States in 2005,[6] and the European Union in 2008, for breast cancer cases where cancer did not respond to other chemotherapy or has relapsed.[7][8] In 2012, the FDA widened the approved uses to include treatment for NSCLC.[2][9] 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.[3]

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.[10] Abraxane is also included on the Schedule of the Australian Pharmaceutical Benefits Scheme although[11] the manufacturer was unable to convince the independent Pharmaceutical Benefits Advisory Committee that the drug warranted a higher price than existing comparator drugs. [12] 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.[13]

In 2010, Abraxis was acquired by Celgene, which now markets Abraxane.[14] Total revenue from the sales of Abraxane for 2009 were $314.5 million.[15] In 2013, Abraxane was FDA approved for the treatment of pancreatic cancer.[16] In 2014, Abraxane's sales were $848 million, 31 percent year-over-year increase.[17]

The British 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.[18]

References

  1. ↑ "Definition of "protein-bound paclitaxel"". National Cancer Institute Dictionary of Cancer Terms. 2011-02-02. http://www.cancer.gov/dictionary?CdrID=507751. 
  2. ↑ 2.0 2.1 "FDA approves Celgene's Abraxane for lung cancer". Reuters. 2012-10-12. https://www.reuters.com/article/us-celgene-abraxane-idUSBRE89B0SQ20121012. 
  3. ↑ 3.0 3.1 "F.D.A. Approves a Drug for Late-Stage Pancreatic Cancer". New York Times. September 7, 2013. https://www.nytimes.com/2013/09/07/business/fda-approves-drug-for-late-stage-pancreatic-cancer.html. 
  4. ↑ "Paclitaxel Albumin-stabilized Nanoparticle Formulation". National Cancer Institute Drug Information. 2006. http://www.cancer.gov/cancertopics/druginfo/nanoparticlepaclitaxel. 
  5. ↑ "Abraxane". September 6, 2013. http://www.orpha.net/consor/cgi-bin/Drugs_Search.php?lng=EN&data_id=101438&search=Drugs_Search_Simple&data_type=Status&Typ=Med. 
  6. ↑ "The Inside Story Of Biotech's Barnum And His Covid Cures" (in en). Forbes. August 27, 2020. https://www.forbes.com/sites/alexknapp/2020/08/27/the-inside-story-of-biotechs-barnum-and-his-covid-cures/. Retrieved 2020-08-27. 
  7. ↑ "FDA Approval for Nanoparticle Paclitaxel". National Cancer Institute Drug Information. 2006. http://www.cancer.gov/cancertopics/druginfo/fda-nanoparticle-paclitaxel. 
  8. ↑ "Abraxane EPAR". 9 March 2020. https://www.ema.europa.eu/en/medicines/human/EPAR/abraxane. 
  9. ↑ "Paclitaxel (Abraxane)". U.S. Food and Drug Administration. October 11, 2012. https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm323668.htm. 
  10. ↑ "Resolution 9190". June 6, 2008. http://www.tga.gov.au/archive/committees-adec-resolutions-0258.htm. 
  11. ↑ "Assessing the safety and cost-effectiveness of early nanodrugs". Journal of Law and Medicine 16 (5): 822–845. May 2009. PMID 19554862. 
  12. ↑ "PBAC, Public Summary Document". November 2008. http://www.health.gov.au/internet/main/publishing.nsf/Content/pbac-psd-paclitaxel-nov08. 
  13. ↑ "Celgene: A Global Biopharmaceutical Company Committed to Improving the Lives of Patients Worldwide with Innovative and Life-Changing Treatments". http://www.abraxisbio.com/rnd_platform_nab.htm. 
  14. ↑ "Celgene Completes Acquisition of Abraxis". Celgene (Press release).
  15. ↑ "Abraxis Reports Phase III Success with Abraxane in First-Line NSCLC". 2010. http://www.genengnews.com/gen-news-highlights/abraxis-reports-phase-iii-success-with-abraxane-in-first-line-nsclc/81243495/. 
  16. ↑ "FDA approves Abraxane for late-stage pancreatic cancer". FDA (Press release).
  17. ↑ "Celgene Corporation Announces 2015 and Long-Term Financial Outlook and Preliminary 2014 Results (NASDAQ:CELG)". Celgene (Press release).
  18. ↑ "NHS England stop access to Abraxane - Pancreatic Cancer UK". September 2015. 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. 

Further reading

External links



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