Protein-bound paclitaxel

Protein-bound paclitaxel
Combination of
Paclitaxel Mitotic inhibitor
Albumin Delivery vehicle
Clinical data
Trade names Abraxane
AHFS/Drugs.com FDA Professional Drug Information
Pregnancy
category
  • US: D (Evidence of risk)
Routes of
administration		 IV
Legal status
Legal status
ChemSpider none
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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 destroys 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 Abraxis BioScience 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 by the U.S. Food and Drug Administration (FDA) in January 2005 and the European Medicines Agency in January 2008 for breast cancer cases where cancer did not respond to other chemotherapy or has relapsed.[6] In June 2010, positive results were published from a phase III trial in first-line non-small-cell lung cancer (NSCLC) when compared with solvent-based paclitaxel,[7] and in October 2012 the FDA widened the approved use of Abraxane to include treatment for NSCLC.[2][8] In September 2013, the FDA approved Abraxane for use in treating advanced pancreatic cancer as a less toxic (although less effective) alternative to FOLFIRINOX.[3]

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] Abraxane 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] based on the originating patents:U.S. Patent 5,439,686,[13] U.S. Patent 5,498,421,[14] U.S. Patent 5,560,933[15] U.S. Patent 5,635,207[16] and U.S. Patent 5,665,382[17]

In 2010, Abraxis was acquired by Celgene, which now markets Abraxane.[18] Total revenue from the sales of Abraxane for 2009 were $314.5 million.[7] In 2013, Abraxane was FDA approved for the treatment of pancreatic cancer.[19] In 2014, Abraxane's sales were $848 million, 31 percent year-over-year increase.[20]

The National Institute for Health and Care Excellence (NICE) announced 17 September 2015 that it would not support the routine use of Abraxane in advanced pancreatic cancer on the NHS.[21]

References

  1. ↑ "Definition of "protein-bound paclitaxel"". National Cancer Institute Dictionary of Cancer Terms.
  2. 1 2 "FDA approves Celgene's Abraxane for lung cancer".
  3. 1 2 Pollack, Andrew (6 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.
  5. ↑ Abraxane, Orpha Net, September 6, 2013, retrieved July 20, 2015
  6. ↑ "FDA Approval for Nanoparticle Paclitaxel". National Cancer Institute Drug Information.
  7. 1 2 "Abraxis Reports Phase III Success with Abraxane in First-Line NSCLC". 2010.
  8. ↑ "Paclitaxel (Abraxane)". U.S. Food and Drug Administration. 11 October 2012. Retrieved 10 December 2012.
  9. ↑ Resolution 9190, Australian Drug Evaluation Committee, 258th meeting resolutions, 6 June 2008.
  10. ↑ Vines T, Faunce T, 'Assessing the safety and cost-effectiveness of early nanodrugs' J Law Med. 2009 May;16(5):822-45 (PMID: 19554862)
  11. ↑ PBAC, Public Summary Document (November 2008).
  12. ↑ "Celgene: A Global Biopharmaceutical Company Committed to Improving the Lives of Patients Worldwide with Innovative and Life-Changing Treatments".
  13. ↑ Desai, N. P.; Soon-Shiong, P.; Sandford, P. A.; Grinstaff, M. W.; Suslick, K. S.; "Methods for In Vivo Delivery of Substantially Water Insoluble Pharmacologically Active Agents and Compositions Useful Therefor"; Aug. 8, 1995.
  14. ↑ Desai, N. P.; Soon-Shiong, P.; Sandford, P. A.; Grinstaff, M. W.; Suslick, K. S.; "Composition Useful for In Vivo Delivery of Biologics and Methods Employing Same"; Mar. 12, 1996.
  15. ↑ Desai, N. P.; Soon-Shiong, P.; Sandford, P. A.; Grinstaff, M. W.; Suslick, K. S.; "Methods for In Vivo Delivery of Substantially Water Insoluble Pharmacologically Active Agents and Compositions for the Use Thereof"; Oct. 1, 1996.
  16. ↑ Grinstaff, M. W.; Soon-Shiong, P.; Wong, M.; Sandford, P. A.; Suslick, K. S.; Desai, N. P. "Methods for the Preparation of Blood Substitutes for In Vivo Delivery”; June 3, 1997.
  17. ↑ Grinstaff, M. W.; Soon-Shiong, P.; Wong, M.; Sandford, P. A.; Suslick, K. S.; Desai, N. P. "Methods for the Preparation of Pharmaceutically Active Agents for In Vivo Delivery”; Sept. 9, 1997.
  18. ↑ Celgene Completes Acquisition of Abraxis
  19. ↑ "Press Announcements - FDA approves Abraxane for late-stage pancreatic cancer".
  20. ↑ "Celgene Corporation Announces 2015 and Long-Term Financial Outlook and Preliminary 2014 Results (NASDAQ:CELG)".
  21. ↑ "NHS England stop access to Abraxane - Pancreatic Cancer UK".

Further reading

Secondary sources

Primary sources

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