Protein-bound paclitaxel

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]

Protein-bound paclitaxel
Combination of
PaclitaxelMitotic inhibitor
AlbuminDelivery vehicle
Clinical data
Trade namesAbraxane
AHFS/Drugs.comFDA Professional Drug Information
Pregnancy
category
  • US: D (Evidence of risk)
    Routes of
    administration    		intravenous (IV)
    ATC code
    Legal status
    Legal status
    • US: ℞-only
    • In general: ℞ (Prescription only)
    Identifiers
    ChemSpider
    • none
     NY (what is this?)  (verify)

    This treatment was approved in the United States in 2005, and the European Union in 2008, for breast cancer cases where cancer did not respond to other chemotherapy or has relapsed.[6][7] In 2012, the FDA widened the approved uses to include treatment for NSCLC.[2][8] 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.[9] Abraxane is also included on the Schedule of the Australian Pharmaceutical Benefits Scheme although[10] the manufacturer was unable to convince the independent Pharmaceutical Benefits Advisory Committee that the drug warranted a higher price than existing comparator drugs. [11] 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.[12]

    In 2010, Abraxis was acquired by Celgene, which now markets Abraxane.[13] Total revenue from the sales of Abraxane for 2009 were $314.5 million.[14] In 2013, Abraxane was FDA approved for the treatment of pancreatic cancer.[15] In 2014, Abraxane's sales were $848 million, 31 percent year-over-year increase.[16]

    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.[17]

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    References
    1. "Definition of "protein-bound paclitaxel"". National Cancer Institute Dictionary of Cancer Terms. February 2, 2011.
    2. "FDA approves Celgene's Abraxane for lung cancer". Reuters. October 12, 2012.
    3. Pollack, Andrew (7 September 2013). "F.D.A. Approves a Drug for Late-Stage Pancreatic Cancer". New York Times. Retrieved 6 September 2013.
    4. "Paclitaxel Albumin-stabilized Nanoparticle Formulation". National Cancer Institute Drug Information. 2006.
    5. "Abraxane". Orpha Net. 6 September 2013. Retrieved 20 July 2015.
    6. "FDA Approval for Nanoparticle Paclitaxel". National Cancer Institute Drug Information. 2006.
    7. "Abraxane EPAR". European Medicines Agency (EMA). 9 March 2020. Retrieved 9 March 2020.
    8. "Paclitaxel (Abraxane)". U.S. Food and Drug Administration. 11 October 2012. Retrieved 10 December 2012.
    9. "Resolution 9190". Australian Drug Evaluation Committee. 6 June 2008.
    10. Vines, T; Faunce, T (May 2009). "Assessing the safety and cost-effectiveness of early nanodrugs". J Law Med. 16 (5): 822–45. PMID 19554862.
    11. "PBAC, Public Summary Document". health.gov.au. November 2008.
    12. "Celgene: A Global Biopharmaceutical Company Committed to Improving the Lives of Patients Worldwide with Innovative and Life-Changing Treatments". www.abraxisbio.com.
    13. "Celgene Completes Acquisition of Abraxis". Celgene (Press release).
    14. "Abraxis Reports Phase III Success with Abraxane in First-Line NSCLC". www.genengnews.com/. 2010.
    15. "FDA approves Abraxane for late-stage pancreatic cancer". FDA (Press release).
    16. "Celgene Corporation Announces 2015 and Long-Term Financial Outlook and Preliminary 2014 Results (NASDAQ:CELG)". Celgene (Press release).
    17. "NHS England stop access to Abraxane - Pancreatic Cancer UK". www.pancreaticcancer.org.uk/. September 2015.

    Further reading
    • "Human albumin". Drug Information Portal. U.S. National Library of Medicine.
    • "Paclitaxel". Drug Information Portal. U.S. National Library of Medicine.
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