| Combination of | |
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| Paclitaxel | Mitotic inhibitor |
| Albumin | Delivery vehicle |
| Clinical data | |
| Trade names | Abraxane, others |
| AHFS/Drugs.com | Monograph |
| MedlinePlus | a619008 |
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| Routes of administration | Intravenous |
| ATC code | |
| Legal status | |
| Legal status | |
| Identifiers | |
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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] In this formulation, paclitaxel is bonded to albumin as a delivery vehicle.[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".[6]
This treatment was approved in the United States in 2005,[7] and the European Union in 2008, for breast cancer cases where cancer did not respond to other chemotherapy or has relapsed.[8][9] In 2012, the FDA widened the approved uses to include treatment for NSCLC.[3][10] 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]
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Transcription
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.[11] Abraxane is also included on the Schedule of the Australian Pharmaceutical Benefits Scheme although[12] the manufacturer was unable to convince the independent Pharmaceutical Benefits Advisory Committee that the drug warranted a higher price than existing comparator drugs. [13] 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.[14]
In 2010, Abraxis was acquired by Celgene, which now markets Abraxane.[15] Total revenue from the sales of Abraxane for 2009 were $314.5 million.[16] In 2013, Abraxane was FDA approved for the treatment of pancreatic cancer.[17] In 2014, Abraxane's sales were $848 million, 31 percent year-over-year increase.[18]
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.[19]
References
- ^ "Product monograph brand safety updates". Health Canada. 7 July 2016. Retrieved 3 April 2024.
- ^ "Definition of "protein-bound paclitaxel"". National Cancer Institute Dictionary of Cancer Terms. February 2, 2011.
- ^ a b "FDA approves Celgene's Abraxane for lung cancer". Reuters. October 12, 2012.
- ^ a b Pollack A (7 September 2013). "F.D.A. Approves a Drug for Late-Stage Pancreatic Cancer". New York Times. Retrieved 6 September 2013.
- ^ "Paclitaxel Albumin-stabilized Nanoparticle Formulation". National Cancer Institute Drug Information. 2006.
- ^ "Abraxane". Orpha Net. 6 September 2013. Retrieved 20 July 2015.
- ^ Knapp A (27 August 2020). "The Inside Story Of Biotech's Barnum And His Covid Cures". Forbes. Retrieved 27 August 2020.
- ^ "FDA Approval for Nanoparticle Paclitaxel". National Cancer Institute Drug Information. 2006.
- ^ "Abraxane EPAR". European Medicines Agency (EMA). 9 March 2020. Retrieved 9 March 2020.
- ^ "Paclitaxel (Abraxane)". U.S. Food and Drug Administration. 11 October 2012. Retrieved 10 December 2012.
- ^ "Resolution 9190". Therapeutic Goods Administration (Tga). 6 June 2008.
- ^ 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.
- ^ "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. doi:10.2147/ijn.s3061. PMC 2720743. PMID 19516888.
- Stinchcombe TE (August 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. PMID 17716129.
- Gradishar WJ (June 2006). "Albumin-bound paclitaxel: a next-generation taxane". Expert Opinion on Pharmacotherapy. 7 (8): 1041–1053. doi:10.1517/14656566.7.8.1041. PMID 16722814. S2CID 12736839.
This page was last edited on 3 April 2024, at 04:40