Protein-bound paclitaxel explained

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] In this formulation, paclitaxel is bonded to albumin as a delivery vehicle.^[2] 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".^[3]

This treatment was approved in the United States in 2005,^[4] and the European Union in 2008, for breast cancer cases where cancer did not respond to other chemotherapy or has relapsed.^{[5] [6]} In 2012, the FDA widened the approved uses to include treatment for NSCLC.^{[7] [8]} 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.^[9]

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.^[10] Abraxane is also included on the Schedule of the Australian Pharmaceutical Benefits Scheme although^[11] the manufacturer was unable to convince the independent Pharmaceutical Benefits Advisory Committee that the drug warranted a higher price than existing comparator drugs.^[12] 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.^[13]

In 2010, Abraxis was acquired by Celgene, which now markets Abraxane.^[14] Total revenue from the sales of Abraxane for 2009 were $314.5 million.^[15] In 2013, Abraxane was FDA approved for the treatment of pancreatic cancer.^[16] In 2014, Abraxane's sales were $848 million, 31 percent year-over-year increase.^[17]

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.^[18]

Further reading

• Miele E, Spinelli GP, Miele E, Tomao F, Tomao S . Albumin-bound formulation of paclitaxel (Abraxane ABI-007) in the treatment of breast cancer . International Journal of Nanomedicine . 4 . 99–105 . 2009 . 19516888 . 2720743 . 10.2147/ijn.s3061 . free .
• Stinchcombe TE . Nanoparticle albumin-bound paclitaxel: a novel Cremphor-EL-free formulation of paclitaxel . Nanomedicine . 2 . 4 . 415–423 . August 2007 . 17716129 . 10.2217/17435889.2.4.415 .
• Gradishar WJ . Albumin-bound paclitaxel: a next-generation taxane . Expert Opinion on Pharmacotherapy . 7 . 8 . 1041–1053 . June 2006 . 16722814 . 10.1517/14656566.7.8.1041 . 12736839 .

Notes and References

1. Web site: Definition of "protein-bound paclitaxel" . National Cancer Institute Dictionary of Cancer Terms . 2011-02-02. mdy-all .
2. Web site: Paclitaxel Albumin-stabilized Nanoparticle Formulation . National Cancer Institute Drug Information . 2006 .
3. Web site: Abraxane. Orpha Net . September 6, 2013 . July 20, 2015 .
4. Knapp A . August 27, 2020. The Inside Story Of Biotech's Barnum And His Covid Cures. 2020-08-27. Forbes. en.
5. Web site: FDA Approval for Nanoparticle Paclitaxel . National Cancer Institute Drug Information . 2006 .
6. Web site: Abraxane EPAR . European Medicines Agency (EMA) . 9 March 2020 . 9 March 2020.
7. News: FDA approves Celgene's Abraxane for lung cancer . mdy-all . Reuters . 2012-10-12 .
8. Web site: Paclitaxel (Abraxane). U.S. Food and Drug Administration. October 11, 2012. 10 December 2012.
9. News: Pollack A . F.D.A. Approves a Drug for Late-Stage Pancreatic Cancer . . September 7, 2013 . September 6, 2013.
10. Web site: Resolution 9190. Therapeutic Goods Administration (Tga). June 6, 2008.
11. Vines T, Faunce T . Assessing the safety and cost-effectiveness of early nanodrugs . Journal of Law and Medicine . 16 . 5 . 822–845 . May 2009 . 19554862 .
12. Web site: PBAC, Public Summary Document. November 2008. health.gov.au.
13. Web site: Celgene: A Global Biopharmaceutical Company Committed to Improving the Lives of Patients Worldwide with Innovative and Life-Changing Treatments. www.abraxisbio.com.
14. Celgene Completes Acquisition of Abraxis. Celgene.
15. Web site: Abraxis Reports Phase III Success with Abraxane in First-Line NSCLC . 2010. www.genengnews.com/ .
16. FDA. FDA approves Abraxane for late-stage pancreatic cancer.
17. Celgene. Celgene Corporation Announces 2015 and Long-Term Financial Outlook and Preliminary 2014 Results (NASDAQ:CELG).
18. Web site: NHS England stop access to Abraxane - Pancreatic Cancer UK. September 2015. www.pancreaticcancer.org.uk/.