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Protein-bound paclitaxel is an injectable formulation of paclitaxel, a mitotic inhibitor drug used in the treatment of breast cancer, lung cancer and pancreatic cancer. In this formulation, paclitaxel is bonded to albumin as a delivery vehicle. It is sometimes called nab-paclitaxel (with the "nab" syllable derived from "nanoparticle albumin–bound"). It is sold in the United States under the trade name Abraxane.
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. 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, and in October 2012 the FDA widened the approved use of Abraxane to include treatment for NSCLC. In September 2013, the FDA approved Abraxane for use in treating advanced pancreatic cancer as a less toxic (although less effective) alternative to FOLFIRINOX
Abraxane is registered on the Australian Register of Therapeutic Goods for the treatment of metastatic carcinoma of the breast after failure of anthracycline therapy. Abraxane is also included on the Schedule of the Australian Pharmaceutical Benefits Scheme although the manufacturer was unable to convince the independent Pharmaceutical Benefits Advisory Committee that the drug warranted a higher price than existing comparator drugs.
Abraxane was developed by Abraxis BioScience as the first in its class of drugs to use the nanoparticle albumin bound (nab) technology platform.[dead link] In 2010, Abraxis was acquired by Celgene, which now markets Abraxane. Total revenue from the sales of Abraxane for 2009 were $314.5 million.
- "Definition of "protein-bound paclitaxel"". National Cancer Institute Dictionary of Cancer Terms.
- "FDA approves Celgene's Abraxane for lung cancer".
- Pollack, Andrew (6 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.
- "FDA Approval for Nanoparticle Paclitaxel". National Cancer Institute Drug Information.
- "Abraxis Reports Phase III Success with Abraxane in First-Line NSCLC". 2010.
- "Paclitaxel (Abraxane)". U.S. Food and Drug Administration. 11 October 2012. Retrieved 10 December 2012.
- Resolution 9190, Australian Drug Evaluation Committee, 258th meeting resolutions, 6 June 2008.
- Vines T, Faunce T, 'Assessing the safety and cost-effectiveness of early nanodrugs' J Law Med. 2009 May;16(5):822-45 (PMID: 19554862)
- PBAC, Public Summary Document (November 2008).
- nab Technology
- Celgene Completes Acquisition of Abraxis
- Gradishar, William J (2006). "Albumin-bound paclitaxel: a next-generation taxane". Expert Opinion on Pharmacotherapy 7 (8): 1041–1053. doi:10.1517/146565126.96.36.1991. ISSN 1465-6566.
- Li, Yankun; Poliks, Barbara; Cegelski, Lynette; Poliks, Mark; Gryczynski, Zygmunt; Piszczek, Grzegorz; Jagtap, Prakash G.; Studelska, Daniel R.; Kingston, David G. I.; Schaefer, Jacob; Bane, Susan (2000). "Conformation of Microtubule-Bound Paclitaxel Determined by Fluorescence Spectroscopy and REDOR NMR†". Biochemistry 39 (2): 281–291. doi:10.1021/bi991936r. ISSN 0006-2960.
- Paik, Younkee; Yang, Chao; Metaferia, Belhu; Tang, Shoubin; Bane, Susan; Ravindra, Rudravajhala; Shanker, Natasha; Alcaraz, Ana A.; Johnson, Scott A.; Schaefer, Jacob; O'Connor, Robert D.; Cegelski, Lynette; Snyder, James P.; Kingston, David G. I. (2007). "Rotational-Echo Double-Resonance NMR Distance Measurements for the Tubulin-Bound Paclitaxel Conformation". Journal of the American Chemical Society 129 (2): 361–370. doi:10.1021/ja0656604. ISSN 0002-7863.
- Green, M. R. (2006). "Abraxane(R), a novel Cremophor(R)-free, albumin-bound particle form of paclitaxel for the treatment of advanced non-small-cell lung cancer". Annals of Oncology 17 (8): 1263–1268. doi:10.1093/annonc/mdl104. ISSN 0923-7534.
- 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:10.2217/174358188.8.131.525. ISSN 1743-5889.
- Stinchcombe, Thomas E.; Socinski, Mark A.; Walko, Christine M.; O’Neil, Bert H.; Collichio, Frances A.; Ivanova, Anastasia; Mu, Hua; Hawkins, Michael J.; Goldberg, Richard M.; Lindley, Celeste; Claire Dees, E. (2007). "Phase I and pharmacokinetic trial of carboplatin and albumin-bound paclitaxel, ABI-007 (Abraxane) on three treatment schedules in patients with solid tumors". Cancer Chemotherapy and Pharmacology 60 (5): 759–766. doi:10.1007/s00280-007-0423-x. ISSN 0344-5704.