Skip to content
Bending the Curve Trial by Trial
?

Microtubule-targeting agentsIn useDerivative of an earlier drugNeeds review

Paclitaxel protein-bound particles (albumin-bound)

Also known as Abraxane, nab-paclitaxel, ABI-007

A formulation of paclitaxel, not a new molecule: the drug is bound to human albumin in particles of about 130 nanometres, without solvents. Its 2026 US label lists metastatic breast, non-small cell lung and pancreatic cancers.

From discovery to approval

  1. 2001 · Earliest report found

    ABI-007, the albumin-bound form of paclitaxel, was described in 2006 as a Cremophor-free, 130-nanometre particle form of the drug. The earliest paper found is a 2001 intra-arterial phase I study of ABI-007; a 2002 intravenous phase I study followed. No source read dates its preclinical development.[2][3][4][5][1][6]

  2. 2005-01-07 · FDA regular

    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 (NDA 21-660, submitted under section 505(b)(2); the letter is dated by its electronic signature, 1/7/05). The type regular is an inference: no accelerated-approval wording was found.[6]

  3. 2008-01-11 · EMA regular

    Marketing authorisation issued 11 January 2008 (EMEA/H/C/000778). The EPAR page lists current indications in metastatic breast cancer, first-line metastatic pancreatic adenocarcinoma with gemcitabine and first-line non-small cell lung cancer with carboplatin; the original 2008 wording is not given there. The page does not mention a conditional or exceptional-circumstances authorisation; the type regular is an inference from that absence.[7]

  4. 2012-10-11 · FDA regular

    In combination with carboplatin, first-line treatment of locally advanced or metastatic non-small cell lung cancer in patients who are not candidates for curative surgery or radiation therapy (NDA 21660/S-031). The type regular is an inference: no accelerated-approval wording was found.[8]

  5. 2013-09-06 · FDA regular

    First-line treatment of patients with metastatic adenocarcinoma of the pancreas, in combination with gemcitabine. The letter has no accelerated-approval wording; type 'regular' is an inference.[9]

How it works

The label says the active drug is paclitaxel, a microtubule inhibitor that promotes the assembly of microtubules from tubulin dimers and stabilises them against depolymerisation. The label also says not to substitute this product for other paclitaxel products.[1]

Where it came from and why

A 2006 preclinical paper says ABI-007 was developed to avoid the toxicities associated with the Cremophor and ethanol vehicle of standard paclitaxel and to use albumin receptor-mediated transport across endothelium. The 2002 phase I paper notes that without Cremophor EL it might be given without routine premedication.

Cancers

  • Metastatic breast cancer

    The US label lists 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.[1]

  • Non-small cell lung cancer

    The label lists first-line treatment, in combination with carboplatin, of locally advanced or metastatic non-small cell lung cancer in patients who are not candidates for curative surgery or radiation therapy.[1]

  • Pancreatic adenocarcinoma

    The label lists first-line treatment, in combination with gemcitabine, of metastatic adenocarcinoma of the pancreas.[1]

Family and partners

Derived from: Paclitaxel

Worth knowing

  • In a phase III trial in metastatic breast cancer (229 patients given ABI-007 and 225 given standard paclitaxel), response rates were 33% against 19% (P = .001) and time to tumour progression 23.0 against 16.9 weeks (hazard ratio 0.75, P = .006), as reported by the authors.[5]
  • In the phase I study, 19 patients received ABI-007 as a 30-minute infusion without premedication; no acute hypersensitivity reactions were seen and the maximum tolerated dose was 300 mg/m2.[3]
  • The label instructs prescribers not to substitute the albumin-bound product for other paclitaxel products.[1]
  • Drugs@FDA classes the original 2005 application as Type 5, a new formulation or new manufacturer, with standard review and orphan status; the approval letter says it was submitted under section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act.[10]

On this site

References

  1. Abraxis BioScience, LLC. Abraxane (paclitaxel protein-bound particles for injectable suspension): prescribing information. DailyMed, set ID 24d10449-2936-4cd3-b7db-a7683db721e4, published 6 April 2026. Source
  2. Damascelli B, Cantù G, Mattavelli F, Tamplenizza P, Bidoli P, Leo E, et al. Intraarterial chemotherapy with polyoxyethylated castor oil free paclitaxel, incorporated in albumin nanoparticles (ABI-007): Phase I study of patients with squamous cell carcinoma of the head and neck and anal canal: preliminary evidence of clinical activity. Cancer. 2001;92(10):2592-602. PubMedDOI
  3. Ibrahim NK, Desai N, Legha S, Soon-Shiong P, Theriault RL, Rivera E, et al. Phase I and pharmacokinetic study of ABI-007, a Cremophor-free, protein-stabilized, nanoparticle formulation of paclitaxel. Clin Cancer Res. 2002;8(5):1038-44. PubMed
  4. Desai N, Trieu V, Yao Z, Louie L, Ci S, Yang A, et al. Increased antitumor activity, intratumor paclitaxel concentrations, and endothelial cell transport of cremophor-free, albumin-bound paclitaxel, ABI-007, compared with cremophor-based paclitaxel. Clin Cancer Res. 2006;12(4):1317-24. PubMedDOI
  5. Gradishar WJ, Tjulandin S, Davidson N, Shaw H, Desai N, Bhar P, et al. Phase III trial of nanoparticle albumin-bound paclitaxel compared with polyethylated castor oil-based paclitaxel in women with breast cancer. J Clin Oncol. 2005;23(31):7794-803. PubMedDOI
  6. U.S. Food and Drug Administration. NDA approval letter, Abraxane (paclitaxel protein-bound particles for injectable suspension), NDA 21-660, American BioScience, Inc.; electronic signature dated 1/7/05. Source
  7. European Medicines Agency. Abraxane (paclitaxel, albumin-bound): EPAR product page (EMEA/H/C/000778); page shows last update 21 January 2026. Read 2026-10-29. Source
  8. U.S. Food and Drug Administration. Supplement approval letter, Abraxane, NDA 21660/S-031, Abraxis BioScience, LLC; electronic signature dated 10/11/2012. Source
  9. US Food and Drug Administration. Approval package, Abraxane (paclitaxel protein-bound particles), NDA 21660/S-037, Abraxis BioScience, LLC; supplement approval letter signed 6 September 2013. Source
  10. U.S. Food and Drug Administration. Drugs@FDA: Approval date(s) and history, letters, labels, reviews for NDA 021660 (paclitaxel protein-bound particles; Abraxane). Page read 2026-10-29. Source