Protein-bound paclitaxel

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]

Protein-bound paclitaxel

Combination of
Paclitaxel	Mitotic inhibitor
Albumin	Delivery vehicle
Clinical data
Trade names	Abraxane, others
AHFS/Drugs.com	Monograph
MedlinePlus	a619008
License data	US DailyMed: Paclitaxel
Pregnancy category	AU: D
Routes of administration	Intravenous
ATC code	L01CD01 (WHO)
Legal status
Legal status	AU: S4 (Prescription only) CA: ℞-only[1] UK: POM (Prescription only) US: ℞-only EU: Rx-only In general: ℞ (Prescription only)
Identifiers
CAS Number	33069-62-4 Y
DrugBank	DB01229 Y
ChemSpider	none
UNII	P88XT4IS4D
KEGG	D00491
NY (what is this?)  (verify)

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]