{ "id": "epnngsanjx", "slug": "nab-paclitaxel-regimen", "title": "Nab-paclitaxel regimen", "updated": "2026-10-15", "topic_path": [ { "id": "life", "label": "Life and health", "api_url": "https://www.edgepedia.org/api/v1/topics/life" }, { "id": "life.health", "label": "Human health and medicine", "api_url": "https://www.edgepedia.org/api/v1/topics/life.health" }, { "id": "life.health.medicines", "label": "Medicines and therapeutics", "api_url": "https://www.edgepedia.org/api/v1/topics/life.health.medicines" }, { "id": "life.health.medicines.cancer-chemotherapy", "label": "Cancer chemotherapy and regimens", "api_url": "https://www.edgepedia.org/api/v1/topics/life.health.medicines.cancer-chemotherapy" }, { "id": "life.health.medicines.cancer-chemotherapy.taxane-and-anthracycline-regimens", "label": "Taxane and anthracycline regimens", "api_url": "https://www.edgepedia.org/api/v1/topics/life.health.medicines.cancer-chemotherapy.taxane-and-anthracycline-regimens" } ], "geo": [ { "id": "geo.nongeo.t2001.life.health.medicines.cancer-chemotherapy", "label": "Non-geographic · 2001 to 2020: Cancer chemotherapy and regimens", "api_url": "https://www.edgepedia.org/api/v1/geo/geo.nongeo.t2001.life.health.medicines.cancer-chemotherapy", "path": [ { "id": "geo.nongeo", "label": "Non-geographic", "api_url": "https://www.edgepedia.org/api/v1/geo/geo.nongeo" }, { "id": "geo.nongeo.t2001", "label": "Non-geographic · 2001 to 2020", "api_url": "https://www.edgepedia.org/api/v1/geo/geo.nongeo.t2001" }, { "id": "geo.nongeo.t2001.life", "label": "Life and health", "api_url": "https://www.edgepedia.org/api/v1/geo/geo.nongeo.t2001.life" }, { "id": "geo.nongeo.t2001.life.health", "label": "Human health and medicine", "api_url": "https://www.edgepedia.org/api/v1/geo/geo.nongeo.t2001.life.health" }, { "id": "geo.nongeo.t2001.life.health.medicines", "label": "Medicines and therapeutics", "api_url": "https://www.edgepedia.org/api/v1/geo/geo.nongeo.t2001.life.health.medicines" }, { "id": "geo.nongeo.t2001.life.health.medicines.cancer-chemotherapy", "label": "Cancer chemotherapy and regimens", "api_url": "https://www.edgepedia.org/api/v1/geo/geo.nongeo.t2001.life.health.medicines.cancer-chemotherapy" } ] } ], "excerpt": "Nab-paclitaxel is a chemotherapy regimen of paclitaxel bound to albumin nanoparticles, FDA approved in 2005 for metastatic breast cancer and later for lung and pancreatic cancer.", "snippet": "Nab-paclitaxel is a chemotherapy regimen of paclitaxel bound to albumin nanoparticles, FDA approved in 2005 for metastatic breast cancer and later for lung and pancreatic cancer.", "node": "life.health.medicines.cancer-chemotherapy.taxane-and-anthracycline-regimens", "markdown": "# Nab-paclitaxel regimen\n\nNab-paclitaxel is a chemotherapy regimen built around paclitaxel bound to human albumin as 130-nm nanoparticles, given alone or combined with agents such as trastuzumab, carboplatin, gemcitabine, or atezolizumab to treat solid tumors including metastatic breast cancer, non-small cell lung cancer (NSCLC), and pancreatic adenocarcinoma.[1](https://link.springer.com/article/10.1007/s00280-015-2833-5) The albumin carrier removes the need for Cremophor EL, the solvent in conventional paclitaxel, so the drug can be infused over 30 minutes without corticosteroid or antihistamine premedication.[2](https://ascopubs.org/doi/10.1200/JCO.2005.04.937) The US Food and Drug Administration (FDA) approved the formulation for metastatic breast cancer on January 7, 2005, for first-line locally advanced or metastatic NSCLC with carboplatin on October 11, 2012, and for first-line metastatic pancreatic adenocarcinoma with gemcitabine on September 6, 2013.[3](https://www.fda.gov/media/133815/download?attachment=)\n\n| Key fact | Detail |\n|---|---|\n| Formulation | Solvent-free, 130-nm albumin-stabilized nanoparticle of paclitaxel[1](https://link.springer.com/article/10.1007/s00280-015-2833-5) |\n| Labeled breast cancer dose | 260 mg/m² intravenously over 30 minutes every 3 weeks, no premedication[4](https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021660lbl.pdf) |\n| Pivotal breast cancer trial | Response rate 33% vs 19% (P=.001) and time to progression 23.0 vs 16.9 weeks (HR 0.75, P=.006) versus solvent-based paclitaxel[2](https://ascopubs.org/doi/10.1200/JCO.2005.04.937) |\n| Toxicity trade-off | Grade 4 neutropenia 9% vs 22%, but grade 3 sensory neuropathy 10% vs 2% versus solvent-based paclitaxel[2](https://ascopubs.org/doi/10.1200/JCO.2005.04.937) |\n| US approvals | Breast cancer 2005; NSCLC with carboplatin 2012; pancreatic cancer with gemcitabine 2013[3](https://www.fda.gov/media/133815/download?attachment=) |\n| Global reach | Approved in 74 countries as of January 6, 2019[3](https://www.fda.gov/media/133815/download?attachment=) |\n| First generic | Sandoz launched the first FDA-approved generic of Abraxane in the US in October 2024[5](https://www.biospace.com/press-releases/sandoz-us-launches-generic-paclitaxel-in-single-dose-vial-further-expanding-us-oncology-portfolio) |\n\n## How it works\n\nPaclitaxel stabilizes microtubules and is cell cycle phase-nonspecific, but the molecule is highly water-insoluble, so conventional paclitaxel requires Cremophor EL (a polyethylated castor oil solvent), which contributes to hypersensitivity reactions and slows infusion.[1](https://link.springer.com/article/10.1007/s00280-015-2833-5) • [6](https://www.bccancer.bc.ca/drug-database-site/Drug%20Index/Paclitaxel%20NAB_monograph.pdf) Nab-paclitaxel replaces that solvent with human serum albumin, forming 130-nm albumin-stabilized nanoparticles.[1](https://link.springer.com/article/10.1007/s00280-015-2833-5)\n\nAlbumin is used as an active carrier, not just a solubilizer. Transendothelial transport of albumin is proposed to be mediated by the gp60 (albondin) receptor on the endothelial surface, which binds albumin with nanomolar affinity; binding activates caveolin-1 and forms caveolae that carry albumin across the endothelial cell into the interstitial space, and albumin's binding to SPARC is proposed to drive peri- and intratumoral accumulation.[1](https://link.springer.com/article/10.1007/s00280-015-2833-5) • [7](https://karger.com/ort/article/37/3/128/327604/Nab-Paclitaxel-for-Metastatic-Pancreatic-Cancer) Preclinical studies showed roughly 10-fold higher endothelial binding and a 4-fold higher transcytosis rate for nab-paclitaxel than for solvent-based paclitaxel, with greater tumor penetration and extravascular distribution.[7](https://karger.com/ort/article/37/3/128/327604/Nab-Paclitaxel-for-Metastatic-Pancreatic-Cancer) • [1](https://link.springer.com/article/10.1007/s00280-015-2833-5)\n\nThis mechanism is disputed. In one experimental study, uptake of Abraxane-derived albumin was less affected by a gp60 pathway inhibitor but significantly reduced by inhibitors of denatured-albumin receptors, indicating a transport mechanism different from endogenous albumin uptake.[8](https://pubs.acs.org/doi/abs/10.1021/acsami.1c03065)\n\n## How it is done\n\nThe labeled regimen for metastatic breast cancer is 260 mg/m² intravenously over 30 minutes every 3 weeks, without premedication.[4](https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021660lbl.pdf) • [9](https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1e9d5093-fbfc-470a-8520-811c46a8870c) In the pivotal trial this 30-minute infusion without premedication was compared with paclitaxel 175 mg/m² as a 3-hour infusion with premedication.[2](https://ascopubs.org/doi/10.1200/JCO.2005.04.937) Because the formulation is solvent-free, it can be given at higher doses over a shorter infusion without corticosteroid premedication.[1](https://link.springer.com/article/10.1007/s00280-015-2833-5)\n\nWeekly schedules are common alternatives: 100 mg/m² on days 1, 8, and 15 of a 28-day cycle in IMpassion130, or weekly dosing in combination regimens.[10](https://www.nejm.org/doi/full/10.1056/NEJMoa1809615)\n\n## Origin\n\nThe formulation was approved by the FDA on January 7, 2005 for metastatic breast cancer after failure of combination chemotherapy or relapse within 6 months of adjuvant chemotherapy; the approval created a new class of protein-bound particle drugs based on the nanoparticle albumin-bound (nab) technology described in the approval announcement.[11](https://www.sec.gov/Archives/edgar/data/1141399/000119312505005450/dex991.htm) The manufacturing process: a paclitaxel–albumin mixture is high-pressure homogenized at 9,000–40,000 psi to form a nanoemulsion, frozen between −20 °C and −80 °C, and lyophilized (freeze-dried for storage).[12](https://www.freepatentsonline.com/y2006/0121119.html) The registration trial randomized 229 patients to nab-paclitaxel 260 mg/m² without premedication and 225 to solvent-based paclitaxel 175 mg/m² with premedication, in 3-week cycles.[2](https://ascopubs.org/doi/10.1200/JCO.2005.04.937) EU centralized marketing authorization followed on January 11, 2008.[3](https://www.fda.gov/media/133815/download?attachment=)\n\n## Variants\n\n**Weekly versus every-3-week dosing.** In a real-world cohort of 102 heavily pretreated metastatic breast cancer patients, weekly nab-paclitaxel 100 mg/m² gave longer PFS than 3-weekly 260 mg/m² (5.5 vs 2.3 months, p<0.001), but with more grade 3/4 neutropenia (40.4% vs 12.0%, p=0.001).[13](https://www.e-crt.org/journal/view.php?number=3298&viewtype=pubreader)\n\n**HER2-positive combinations.** A phase II trial evaluated weekly nab-paclitaxel with carboplatin and trastuzumab as first-line therapy for HER2-overexpressing metastatic breast cancer.[14](https://pmc.ncbi.nlm.nih.gov/articles/PMC3883128/) In the neoadjuvant setting, four cycles of nab-paclitaxel 260 mg/m² q3w with trastuzumab followed by four cycles of FEC achieved a pathological complete response rate of 74.0% in 29 patients.[15](https://ar.iiarjournals.org/content/39/4/2053) The HELEN-006 multicenter randomized phase 3 trial compared de-escalated neoadjuvant weekly nab-paclitaxel with trastuzumab and pertuzumab against the docetaxel–carboplatin–trastuzumab–pertuzumab regimen in HER2-positive early breast cancer.[16](https://pubmed.ncbi.nlm.nih.gov/39612919/)\n\n**Immunotherapy combinations.** In IMpassion130, atezolizumab 840 mg or placebo on days 1 and 15 was added to nab-paclitaxel 100 mg/m² on days 1, 8, and 15 of 28-day cycles in advanced triple-negative breast cancer; nab-paclitaxel was chosen as the chemotherapy partner because the glucocorticoid premedication required with solvent-based paclitaxel had been hypothesized to affect immunotherapy activity.[10](https://www.nejm.org/doi/full/10.1056/NEJMoa1809615) Phase II studies have also paired nab-paclitaxel with gemcitabine, capecitabine, carboplatin, bevacizumab, and trastuzumab in metastatic breast cancer.[17](https://www.nature.com/articles/s41598-019-57380-0)\n\n## Applications\n\n**Metastatic breast cancer.** In the pivotal phase III trial, nab-paclitaxel produced a higher investigator-assessed response rate (33% vs 19%, P=.001) and longer time to progression (23.0 vs 16.9 weeks; HR 0.75, P=.006) than solvent-based paclitaxel.[2](https://ascopubs.org/doi/10.1200/JCO.2005.04.937) The FDA label reports the trial's primary endpoint, the reconciled target lesion response rate, as 21.5% (95% CI 16.2–26.7%) versus 11.1% (95% CI 6.9–15.1%), with no statistically significant overall survival difference between arms.[4](https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021660lbl.pdf) • [18](https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/216338Orig1s000IntegratedR.pdf) A meta-analysis of 5 randomized trials (1,554 patients) found nab-paclitaxel superior to solvent-based paclitaxel on response rate (OR 2.39, 95% CI 1.69–3.37) and PFS (HR 0.75, 95% CI 0.62–0.90), and superior to docetaxel on overall survival (HR 0.73, 95% CI 0.54–0.99).[17](https://www.nature.com/articles/s41598-019-57380-0)\n\n**NSCLC.** In the phase III first-line trial, nab-paclitaxel plus carboplatin improved response rate versus solvent-based paclitaxel plus carboplatin (33% vs 25%; P=0.005) but showed no significant difference in median PFS (6.3 vs 5.8 months) or OS (12.1 vs 11.2 months).[19](https://pmc.ncbi.nlm.nih.gov/articles/PMC4521678/)\n\n**Pancreatic cancer.** The FDA approved nab-paclitaxel with gemcitabine as first-line therapy for metastatic pancreatic adenocarcinoma in September 2013.[3](https://www.fda.gov/media/133815/download?attachment=)\n\n## Limitations and alternatives\n\n**Neuropathy is the dose-limiting toxicity.** Grade 3 sensory neuropathy was more common with nab-paclitaxel than solvent-based paclitaxel in the pivotal trial (10% vs 2%, P<.001), though it improved with a median of 22 days.[2](https://ascopubs.org/doi/10.1200/JCO.2005.04.937) The meta-analysis confirmed more grade ≥3 sensory neuropathy (OR 2.44, 95% CI 1.42–4.20) and less grade ≥3 neutropenia (OR 0.26, 95% CI 0.09–0.78) versus solvent-based taxanes.[17](https://www.nature.com/articles/s41598-019-57380-0) In the pancreatic combination, grade 3 neuropathy was 17% vs 1% with gemcitabine alone, with a median time to onset of about 4.5 months and improvement to grade 1 or lower in a median of 29 days.[7](https://karger.com/ort/article/37/3/128/327604/Nab-Paclitaxel-for-Metastatic-Pancreatic-Cancer) In NSCLC, grade ≥3 neutropenia (47% vs 58%) and sensory neuropathy (3% vs 12%) were less frequent with nab-paclitaxel, while thrombocytopenia (18% vs 9%) and anemia (27% vs 7%) were more common.[19](https://pmc.ncbi.nlm.nih.gov/articles/PMC4521678/) No hypersensitivity reactions occurred in the pivotal trial despite no premedication.[2](https://ascopubs.org/doi/10.1200/JCO.2005.04.937)\n\n**Comparative positioning is mixed.** In CALGB 40502, weekly nab-paclitaxel was not superior to weekly solvent-based paclitaxel with bevacizumab (PFS 9.3 vs 11 months; HR 1.20, 95% CI 1.00–1.45).[20](https://pubmed.ncbi.nlm.nih.gov/26056183/) A cost-utility analysis found nab-paclitaxel had the most favorable safety profile of the three taxanes but a higher cost per course than paclitaxel or docetaxel.[21](https://www.dovepress.com/nab-paclitaxel-docetaxel-or-solvent-based-paclitaxel-in-metastatic-bre-peer-reviewed-fulltext-article-CEOR) Current payer guidelines position albumin-bound paclitaxel in first-line metastatic triple-negative breast cancer only when PD-L1 CPS <10 and no germline BRCA1/2 mutation is present, and recommend it with pembrolizumab for PD-L1 CPS ≥10 disease.[22](https://info.nanthealth.com/hubfs/clinical-guidelines/Medical%20Oncology/Paclitaxel%20albumin-bound%20-%20NH.pdf)\n\n**Recent changes.** The lyophilized 100 mg single-dose vial is a generic of Abraxane (paclitaxel protein-bound particles for injectable suspension, albumin-bound) in the US, and is an ANDA referencing Abraxane.[5](https://www.biospace.com/press-releases/sandoz-us-launches-generic-paclitaxel-in-single-dose-vial-further-expanding-us-oncology-portfolio)\n\n## References\n\n1. [Albumin-bound nanoparticle (nab) paclitaxel exhibits enhanced paclitaxel tissue distribution and tumor penetration (Cancer Chemotherapy and Pharmacology)](https://link.springer.com/article/10.1007/s00280-015-2833-5)\n2. [Phase III Trial of Nanoparticle Albumin-Bound Paclitaxel Compared With Polyethylated Castor Oil–Based Paclitaxel in Women With Breast Cancer](https://ascopubs.org/doi/10.1200/JCO.2005.04.937)\n3. [FDA Clinical Review of nab-paclitaxel](https://www.fda.gov/media/133815/download?attachment=)\n4. [FDA label for ABRAXANE (2005)](https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021660lbl.pdf)\n5. [Sandoz US launches generic paclitaxel in single-dose vial](https://www.biospace.com/press-releases/sandoz-us-launches-generic-paclitaxel-in-single-dose-vial-further-expanding-us-oncology-portfolio)\n6. [BC Cancer Drug Index monograph: Paclitaxel, nanoparticle, albumin-bound (nab)](https://www.bccancer.bc.ca/drug-database-site/Drug%20Index/Paclitaxel%20NAB_monograph.pdf)\n7. [Nab-Paclitaxel for Metastatic Pancreatic Cancer: Clinical Outcomes and Potential Mechanisms of Action (Oncology Research and Treatment)](https://karger.com/ort/article/37/3/128/327604/Nab-Paclitaxel-for-Metastatic-Pancreatic-Cancer)\n8. [Evidence for Delivery of Abraxane via a Denatured-Albumin Transport System (ACS Applied Materials & Interfaces)](https://pubs.acs.org/doi/abs/10.1021/acsami.1c03065)\n9. [DailyMed label: Paclitaxel protein-bound particles for injectable suspension (albumin-bound)](https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1e9d5093-fbfc-470a-8520-811c46a8870c)\n10. [Atezolizumab and Nab-Paclitaxel in Advanced Triple-Negative Breast Cancer](https://www.nejm.org/doi/full/10.1056/NEJMoa1809615)\n11. [Press Release: FDA approval of ABRAXANE, January 7, 2005 (American Pharmaceutical Partners / American Bioscience)](https://www.sec.gov/Archives/edgar/data/1141399/000119312505005450/dex991.htm)\n12. [US patent application: Process for producing nanoparticles of paclitaxel and albumin (American Bioscience Inc.)](https://www.freepatentsonline.com/y2006/0121119.html)\n13. [A Real-World Efficacy of Nab-Paclitaxel Monotherapy in Metastatic Breast Cancer](https://www.e-crt.org/journal/view.php?number=3298&viewtype=pubreader)\n14. [Phase II Trial of Weekly Nanoparticle Albumin-Bound Paclitaxel With Carboplatin and Trastuzumab as First-line Therapy for Women With HER2-Overexpressing Metastatic Breast Cancer](https://pmc.ncbi.nlm.nih.gov/articles/PMC3883128/)\n15. [Neoadjuvant Chemotherapy With Nab-paclitaxel Plus Trastuzumab Followed by FEC for HER2-positive Operable Breast Cancer: A Multicenter Phase II Trial](https://ar.iiarjournals.org/content/39/4/2053)\n16. [De-escalated neoadjuvant weekly nab-paclitaxel with trastuzumab and pertuzumab versus docetaxel, carboplatin, trastuzumab, and pertuzumab (HELEN-006)](https://pubmed.ncbi.nlm.nih.gov/39612919/)\n17. [Efficacy and safety of nanoparticle-albumin-bound paclitaxel compared with solvent-based taxanes for metastatic breast cancer: A meta-analysis (Scientific Reports)](https://www.nature.com/articles/s41598-019-57380-0)\n18. [FDA Integrated Review, NDA 216338 (paclitaxel protein-bound particles, albumin-bound)](https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/216338Orig1s000IntegratedR.pdf)\n19. [Albumin-bound paclitaxel in solid tumors: clinical development and future directions](https://pmc.ncbi.nlm.nih.gov/articles/PMC4521678/)\n20. [Randomized Phase III Trial of Paclitaxel Once Per Week Compared With Nab-Paclitaxel Once Per Week or Ixabepilone With Bevacizumab As First-Line Chemotherapy for Locally Recurrent or Metastatic Breast Cancer: CALGB 40502/NCCTG N063H (Alliance)](https://pubmed.ncbi.nlm.nih.gov/26056183/)\n21. [Nab-paclitaxel, docetaxel, or solvent-based paclitaxel in metastatic breast cancer: cost-utility analysis (China)](https://www.dovepress.com/nab-paclitaxel-docetaxel-or-solvent-based-paclitaxel-in-metastatic-bre-peer-reviewed-fulltext-article-CEOR)\n22. [NANTHealth clinical guideline: Paclitaxel albumin-bound](https://info.nanthealth.com/hubfs/clinical-guidelines/Medical%20Oncology/Paclitaxel%20albumin-bound%20-%20NH.pdf)\n\n---\n*Topic: Encyclopedia › Life and health › Human health and medicine › Medicines and therapeutics › Cancer chemotherapy and regimens › Taxane and anthracycline regimens*\n\n*Initially written Sep 29, 2026 · Edited: Oct 15, 2026*\n\n*Copyright 2026 EdgeChat AI, a subsidiary of Biostate AI.*\n\nLicense: Edgepedia Community License 1.0, https://www.edgepedia.org/edgepedia/license\n", "same_as": [], "url": "https://www.edgepedia.org/nab-paclitaxel-regimen", "markdown_url": "https://www.edgepedia.org/nab-paclitaxel-regimen.md", "license": { "name": "Edgepedia Community License 1.0", "url": "https://www.edgepedia.org/edgepedia/license", "summary": "Free with credit, commercial use included. AI training is open to everyone. For other uses, organizations over USD 100M in revenue or 100M monthly users license separately.", "spdx": "LicenseRef-Edgepedia-Community-1.0" }, "credit": "\"Nab-paclitaxel regimen\", Edgepedia (EdgeChat), https://www.edgepedia.org/nab-paclitaxel-regimen. Edgepedia Community License 1.0.", "credit_md": "\"[Nab-paclitaxel regimen](https://www.edgepedia.org/nab-paclitaxel-regimen)\", Edgepedia (EdgeChat), [https://www.edgepedia.org/nab-paclitaxel-regimen](https://www.edgepedia.org/nab-paclitaxel-regimen). [Edgepedia Community License 1.0](https://www.edgepedia.org/edgepedia/license).", "credit_html": "\"Nab-paclitaxel regimen\", Edgepedia (EdgeChat), https://www.edgepedia.org/nab-paclitaxel-regimen. Edgepedia Community License 1.0.", "speakable": "Nab-paclitaxel is a chemotherapy regimen of paclitaxel bound to albumin nanoparticles, FDA approved in 2005 for metastatic breast cancer and later for lung and pancreatic cancer." }