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]
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Paclitaxel | Mitotic inhibitor |
Albumin | Delivery vehicle |
Clinical data | |
Trade names | Abraxane |
AHFS/Drugs.com | FDA Professional Drug Information |
Pregnancy category |
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Routes of administration | IV |
Legal status | |
Legal status |
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ChemSpider |
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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
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
- "Definition of "protein-bound paclitaxel"". National Cancer Institute Dictionary of Cancer Terms. February 2, 2011.
- "FDA approves Celgene's Abraxane for lung cancer". Reuters. October 12, 2012.
- Pollack, Andrew (September 7, 2013). "F.D.A. Approves a Drug for Late-Stage Pancreatic Cancer". New York Times. Retrieved September 6, 2013.
- "Paclitaxel Albumin-stabilized Nanoparticle Formulation". National Cancer Institute Drug Information. 2006.
- "Abraxane". Orpha Net. September 6, 2013. Retrieved July 20, 2015.
- "FDA Approval for Nanoparticle Paclitaxel". National Cancer Institute Drug Information. 2006.
- "Paclitaxel (Abraxane)". U.S. Food and Drug Administration. October 11, 2012. Retrieved 10 December 2012.
- "Resolution 9190". Australian Drug Evaluation Committee. June 6, 2008.
- Vines, T; Faunce, T (May 2009). "Assessing the safety and cost-effectiveness of early nanodrugs". J Law Med. 16 (5): 822–45. PMID 19554862.
- "PBAC, Public Summary Document". health.gov.au. November 2008.
- "Celgene: A Global Biopharmaceutical Company Committed to Improving the Lives of Patients Worldwide with Innovative and Life-Changing Treatments". www.abraxisbio.com.
- "Celgene Completes Acquisition of Abraxis". Celgene (Press release).
- "Abraxis Reports Phase III Success with Abraxane in First-Line NSCLC". www.genengnews.com/. 2010.
- "FDA approves Abraxane for late-stage pancreatic cancer". FDA (Press release).
- "Celgene Corporation Announces 2015 and Long-Term Financial Outlook and Preliminary 2014 Results (NASDAQ:CELG)". Celgene (Press release).
- "NHS England stop access to Abraxane - Pancreatic Cancer UK". www.pancreaticcancer.org.uk/. September 2015.
Further reading
- Miele E, Spinelli GP, Miele E, Tomao F, Tomao S (2009). "Albumin-bound formulation of paclitaxel (Abraxane ABI-007) in the treatment of breast cancer". International Journal of Nanomedicine. 4: 99–105. PMC 2720743. PMID 19516888. Retrieved 2012-08-27.
- Stinchcombe, Thomas E (2007). "Nanoparticle albumin-bound paclitaxel: a novel Cremphor-EL®-free formulation of paclitaxel". Nanomedicine. 2 (4): 415–423. doi:10.2217/17435889.2.4.415. ISSN 1743-5889. PMID 17716129.
- Gradishar, William J (2006). "Albumin-bound paclitaxel: a next-generation taxane". Expert Opinion on Pharmacotherapy. 7 (8): 1041–1053. doi:10.1517/14656566.7.8.1041. ISSN 1465-6566. PMID 16722814.