Protein-bound paclitaxel
In this article we will explore the topic of Protein-bound paclitaxel from different perspectives, with the aim of analyzing its impact on modern society. From its origin to its influence today, we will take a tour of the most relevant aspects related to Protein-bound paclitaxel. In addition, we will examine the possible implications and consequences that Protein-bound paclitaxel may have in various areas, as well as the future perspectives that this topic raises. Through a detailed and exhaustive analysis, we will try to shed light on Protein-bound paclitaxel and its relevance in the contemporary world.
 | This scientific article needs additional citations to secondary or tertiary sources. (November 2016) |
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| Paclitaxel | Mitotic inhibitor |
| Albumin | Delivery vehicle |
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| Trade names | Abraxane, others |
| AHFS/Drugs.com | Monograph |
| MedlinePlus | a619008 |
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| Routes of administration | Intravenous |
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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]
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
- ^ "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.
- ^ a b "Nab-paclitaxel (Abraxane)". www.cancerresearchuk.org. Retrieved 13 April 2025.
- ^ "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. Archived from the original on 24 July 2008. Retrieved 18 February 2008.
- ^ "Abraxane EPAR". European Medicines Agency (EMA). 9 March 2020. Retrieved 9 March 2020.
- ^ "Paclitaxel (Abraxane)". U.S. Food and Drug Administration. 11 October 2012. Archived from the original on 14 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). Archived from the original on 9 September 2013.
- ^ "Celgene Corporation Announces 2015 and Long-Term Financial Outlook and Preliminary 2014 Results (NASDAQ:CELG)". Celgene (Press release).
- ^ Kansteiner F (9 November 2022). "Bristol Myers' subsidiary behind cancer blockbuster Abraxane slapped with FDA warning letter". Fierce Pharma. Retrieved 12 March 2025.
- ^ "NHS England stop access to Abraxane - Pancreatic Cancer UK". www.pancreaticcancer.org.uk/. September 2015.[permanent dead link]
- ^ "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.
- ^ 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.
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.
