Paclitaxel, nanoparticle albumin-bound (Abraxane)

General information

Class/mechanism: Taxane, promotes assembly of microtubules, stablizes microtubules, preventing depolymerization. Paclitaxel interferes with the normal dynamic reorganization of microtubules that is necessary for regular interphase/mitosis processes. It also leads to creation of abnormal bundles of microtubules. The nanoparticle albumin bound characteristic of Abraxane eliminates the need for it to be dissolved in Cremophor EL (polyoxyethylated castor oil) like Paclitaxel (Taxol) and the risk of hypersensitivity infusion reactions related to Cremophor.
Route: IV
Extravasation: irritant

For conciseness and simplicity, HemOnc.org currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. Instead, for the most current information, please refer to your preferred pharmacopeias such as Micromedex, Lexicomp, UpToDate (courtesy of Lexicomp), or the prescribing information.

Diseases for which it is established

• Breast cancer
• Non-small cell lung cancer
• Pancreatic cancer

Diseases for which it is used

• Cholangiocarcinoma
• Gallbladder cancer
• Gastric cancer
• Melanoma
• Non-small cell lung cancer, nonsquamous
• Non-small cell lung cancer, squamous
• Ovarian cancer
• Urothelial carcinoma

Patient drug information

• Paclitaxel, nanoparticle albumin-bound (Abraxane) package insert
• Paclitaxel, nanoparticle albumin-bound (Abraxane) patient drug information (Chemocare)
• Paclitaxel, nanoparticle albumin-bound (Abraxane) patient drug information (UpToDate)

History of changes in FDA indication

• 2005-01-07: FDA approved for metastatic breast cancer, after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated. (Based on CA012-0 & Ibrahim et al. 2005)
• 2012-10-11: FDA approved for locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC), as first-line treatment in combination with carboplatin, in patients who are not candidates for curative surgery or radiation therapy. (Based on CA031)
• 2013-09-06: FDA approved for treatment of metastatic adenocarcinoma of the pancreas as first-line treatment, in combination with gemcitabine. (Based on MPACT)

History of changes in EMA indication

• 2008-01-11: Initial marketing authorization as Abraxane

History of changes in Health Canada indication

• 2006-06-07: Initial notice of compliance (unclear details)
• 2014-07-16: New indication for the first-line treatment of locally advanced unresectable or metastatic adenocarcinoma of the pancreas, in combination with gemcitabine.

History of changes in PMDA indication

• 2010-07-23: Initial approval in a new dosage form and with a new dosage indicated for the treatment of breast cancer.
• 2013-02-21: New additional indications and a new dosage for the treatment of gastric cancer and non-small cell lung cancer.
• 2014-12-18: New additional indication and a new dosage for the treatment of unresectable pancreatic cancer.

Also known as

• Code name: ABI-007
• Generic names: ab-pac, ab-paclitaxel, albumin-bound paclitaxel, nab-paclitaxel, paclitaxel protein-bound, paclitaxel protein-bound particles for injectable suspension (albumin-bound)
• Brand name: Abraxane