Protein-bound paclitaxel

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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
IV
Legal status
Legal status
Identifiers
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 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 and the Europe in 2008 for breast cancer cases where cancer did not respond to other chemotherapy or has relapsed.[6] In 2012 the FDA widened the approved uses to include treatment for NSCLC.[2][7] 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[edit]

Abraxane is registered on the Australian Register of Therapeutic Goods for the treatment of metastatic carcinoma of the breast after failure of anthracycline therapy.[8] Abraxane is also included on the Schedule of the Australian Pharmaceutical Benefits Scheme although[9] the manufacturer was unable to convince the independent Pharmaceutical Benefits Advisory Committee that the drug warranted a higher price than existing comparator drugs. [10] 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.[11]

In 2010, Abraxis was acquired by Celgene, which now markets Abraxane.[12] Total revenue from the sales of Abraxane for 2009 were $314.5 million.[13] In 2013, Abraxane was FDA approved for the treatment of pancreatic cancer.[14] In 2014, Abraxane's sales were $848 million, 31 percent year-over-year increase.[15]

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.[16]

References[edit]

  1. ^ "Definition of "protein-bound paclitaxel"". National Cancer Institute Dictionary of Cancer Terms.
  2. ^ a b "FDA approves Celgene's Abraxane for lung cancer".
  3. ^ a b 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. ^ "Paclitaxel (Abraxane)". U.S. Food and Drug Administration. 11 October 2012. Retrieved 10 December 2012.
  8. ^ Resolution 9190, Australian Drug Evaluation Committee, 258th meeting resolutions, 6 June 2008.
  9. ^ Vines T, Faunce T, 'Assessing the safety and cost-effectiveness of early nanodrugs' J Law Med. 2009 May;16(5):822-45 (PMID: 19554862)
  10. ^ PBAC, Public Summary Document (November 2008).
  11. ^ "Celgene: A Global Biopharmaceutical Company Committed to Improving the Lives of Patients Worldwide with Innovative and Life-Changing Treatments".
  12. ^ Celgene Completes Acquisition of Abraxis
  13. ^ "Abraxis Reports Phase III Success with Abraxane in First-Line NSCLC". 2010.
  14. ^ "Press Announcements - FDA approves Abraxane for late-stage pancreatic cancer".
  15. ^ "Celgene Corporation Announces 2015 and Long-Term Financial Outlook and Preliminary 2014 Results (NASDAQ:CELG)".
  16. ^ "NHS England stop access to Abraxane - Pancreatic Cancer UK".

Further reading[edit]