Protein-bound paclitaxel

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Protein-bound paclitaxel
Combination of
Paclitaxel Mitotic inhibitor
Albumin Delivery vehicle
Clinical data
Trade names Abraxane, others
AHFS/Drugs.com Monograph
MedlinePlus a619008
License data
Pregnancy
category
  • AU:D
Routes of
administration 		Intravenous
ATC code
Legal status
Legal status
  • AU: S4 (Prescription only)
  • CA: ℞-only [1]
  • UK: POM (Prescription only)
  • US: ℞-only
  • EU:Rx-only
  • In general: ℞ (Prescription only)
Identifiers
CAS Number
DrugBank
ChemSpider
  • none
UNII
KEGG
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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. [2] [3] [4] [5] In this formulation, paclitaxel is bonded to albumin as a delivery vehicle. [6] [5] 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". [7]

Contents

This treatment was approved in the United States in 2005, [8] and the European Union in 2008, for breast cancer cases where cancer did not respond to other chemotherapy or has relapsed. [9] [10] In 2012, the FDA widened the approved uses to include treatment for NSCLC. [3] [11] 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. [4]

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. [12] Abraxane is also included on the Schedule of the Australian Pharmaceutical Benefits Scheme although [13] the manufacturer was unable to convince the independent Pharmaceutical Benefits Advisory Committee that the drug warranted a higher price than existing comparator drugs. [14] 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. [15]

In 2010, Abraxis was acquired by Celgene, which now markets Abraxane. [16] Total revenue from the sales of Abraxane for 2009 were $314.5 million. [17] In 2013, Abraxane was FDA approved for the treatment of pancreatic cancer. [18] In 2014, Abraxane's sales were $848 million, 31 percent year-over-year increase. [19] In 2019 Bristol Meyers Squibb acquired Celgene for $74 billion dollars, and thus acquired Abraxis Bioscience and the rights to manufacture and market Abraxane. [20]

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. [21] However, this decision was changed in September 2017. [22] It has continued to be reimbursed in England since then, despite questionable real world effectiveness. [23]

References

  1. ↑ "Product monograph brand safety updates". Health Canada . 7 July 2016. Retrieved 3 April 2024.
  2. ↑ "Definition of "protein-bound paclitaxel"". National Cancer Institute Dictionary of Cancer Terms. February 2, 2011.
  3. 1 2 "FDA approves Celgene's Abraxane for lung cancer". Reuters. October 12, 2012.
  4. 1 2 Pollack A (7 September 2013). "F.D.A. Approves a Drug for Late-Stage Pancreatic Cancer". New York Times . Retrieved 6 September 2013.
  5. 1 2 "Nab-paclitaxel (Abraxane)". www.cancerresearchuk.org. Retrieved 13 April 2025.
  6. ↑ "Paclitaxel Albumin-stabilized Nanoparticle Formulation". National Cancer Institute Drug Information. 2006.
  7. ↑ "Abraxane". Orpha Net. 6 September 2013. Retrieved 20 July 2015.
  8. ↑ Knapp A (27 August 2020). "The Inside Story Of Biotech's Barnum And His Covid Cures". Forbes. Retrieved 27 August 2020.
  9. ↑ "FDA Approval for Nanoparticle Paclitaxel". National Cancer Institute Drug Information. 2006.
  10. ↑ "Abraxane EPAR". European Medicines Agency (EMA). 9 March 2020. Retrieved 9 March 2020.
  11. ↑ "Paclitaxel (Abraxane)". U.S. Food and Drug Administration. 11 October 2012. Archived from the original on 14 October 2012. Retrieved 10 December 2012.
  12. ↑ "Resolution 9190". Therapeutic Goods Administration (Tga). 6 June 2008.
  13. ↑ Vines T, Faunce T (May 2009). "Assessing the safety and cost-effectiveness of early nanodrugs". Journal of Law and Medicine. 16 (5): 822–845. PMID   19554862.
  14. ↑ "PBAC, Public Summary Document". health.gov.au. November 2008.
  15. ↑ "Celgene: A Global Biopharmaceutical Company Committed to Improving the Lives of Patients Worldwide with Innovative and Life-Changing Treatments". www.abraxisbio.com.
  16. ↑ "Celgene Completes Acquisition of Abraxis". Celgene (Press release).
  17. ↑ "Abraxis Reports Phase III Success with Abraxane in First-Line NSCLC". www.genengnews.com/. 2010.
  18. ↑ "FDA approves Abraxane for late-stage pancreatic cancer". FDA (Press release). Archived from the original on 9 September 2013.
  19. ↑ "Celgene Corporation Announces 2015 and Long-Term Financial Outlook and Preliminary 2014 Results (NASDAQ:CELG)". Celgene (Press release).
  20. ↑ Kansteiner F (9 November 2022). "Bristol Myers' subsidiary behind cancer blockbuster Abraxane slapped with FDA warning letter". Fierce Pharma. Retrieved 12 March 2025.
  21. ↑ "NHS England stop access to Abraxane - Pancreatic Cancer UK". www.pancreaticcancer.org.uk/. September 2015.
  22. ↑ "Overview | Paclitaxel as albumin-bound nanoparticles with gemcitabine for untreated metastatic pancreatic cancer | Guidance | NICE". www.nice.org.uk. 6 September 2017. Retrieved 26 December 2024.
  23. ↑ Wadd N, Peedell C, Polwart C (August 2022). "Real-World Assessment of Cancer Drugs Using Local Data Uploaded to the Systemic Anti-Cancer Therapy Dataset in England". Clinical Oncology. 34 (8): 497–507. doi:10.1016/j.clon.2022.04.012. PMID   35584974.

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