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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. In this formulation, paclitaxel is bonded to albumin as a delivery vehicle. 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".

This treatment was approved in the United States in 2005, and the European Union in 2008, for breast cancer cases where cancer did not respond to other chemotherapy or has relapsed. In 2012, the FDA widened the approved uses to include treatment for NSCLC. 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.

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. 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. 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.

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

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. However, this decision was changed in September 2017. It has continued to be reimbursed in England since then, despite questionable real world effectiveness.

References

1. "Product monograph brand safety updates". Health Canada. 7 July 2016. Retrieved 3 April 2024.
2. "Definition of "protein-bound paclitaxel"". National Cancer Institute Dictionary of Cancer Terms. February 2, 2011.
3. ^ "FDA approves Celgene's Abraxane for lung cancer". Reuters. October 12, 2012.
4. ^ Pollack A (7 September 2013). "F.D.A. Approves a Drug for Late-Stage Pancreatic Cancer". New York Times. Retrieved 6 September 2013.
5. "Paclitaxel Albumin-stabilized Nanoparticle Formulation". National Cancer Institute Drug Information. 2006.
6. "Abraxane". Orpha Net. 6 September 2013. Retrieved 20 July 2015.
7. Knapp A (27 August 2020). "The Inside Story Of Biotech's Barnum And His Covid Cures". Forbes. Retrieved 27 August 2020.
8. "FDA Approval for Nanoparticle Paclitaxel". National Cancer Institute Drug Information. 2006.
9. "Abraxane EPAR". European Medicines Agency (EMA). 9 March 2020. Retrieved 9 March 2020.
10. "Paclitaxel (Abraxane)". U.S. Food and Drug Administration. 11 October 2012. Retrieved 10 December 2012.
11. "Resolution 9190". Therapeutic Goods Administration (Tga). 6 June 2008.
12. 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.
13. "PBAC, Public Summary Document". health.gov.au. November 2008.
14. "Celgene: A Global Biopharmaceutical Company Committed to Improving the Lives of Patients Worldwide with Innovative and Life-Changing Treatments". www.abraxisbio.com.
15. "Celgene Completes Acquisition of Abraxis". Celgene (Press release).
16. "Abraxis Reports Phase III Success with Abraxane in First-Line NSCLC". www.genengnews.com/. 2010.
17. "FDA approves Abraxane for late-stage pancreatic cancer". FDA (Press release).
18. "Celgene Corporation Announces 2015 and Long-Term Financial Outlook and Preliminary 2014 Results (NASDAQ:CELG)". Celgene (Press release).
19. "NHS England stop access to Abraxane - Pancreatic Cancer UK". www.pancreaticcancer.org.uk/. September 2015.
20. "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.
21. 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.

• Medicine

• Breast cancer
• Drugs developed by Bristol Myers Squibb
• Mitotic inhibitors
• Orphan drugs