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Microtubule-targeting agentsIn useDerivative of an earlier drug

Cabazitaxel

Also known as Jevtana, XRP6258, RPR 116258A

A semisynthetic taxane given by infusion, prepared from a precursor extracted from yew needles. Its US label lists treatment, with prednisone, of metastatic castration-resistant prostate cancer previously treated with a docetaxel-containing regimen.

From discovery to approval

  1. 2006 · Earliest report found

    A 2006 review lists XRP6258, the code name of cabazitaxel, among semisynthetic taxane derivatives in clinical development. The 2025 US label says it is prepared by semisynthesis from a precursor extracted from yew needles. No source read dates its first synthesis.[2][3][4][5][1]

  2. 2010-06-17 · FDA regular

    In combination with prednisone for patients with hormone-refractory metastatic prostate cancer previously treated with a docetaxel-containing regimen. The letter contains no accelerated-approval (subpart H) wording; the type 'regular' is an inference from that absence.[6]

  3. 2011-03-17 · EMA regular

    Marketing authorisation issued 17 March 2011 (EMEA/H/C/002018), with the CHMP opinion adopted on 20 January 2011. The EPAR page lists, with prednisone or prednisolone, hormone-refractory metastatic prostate cancer previously treated with a docetaxel-containing regimen. The page does not mention a conditional or exceptional-circumstances authorisation; the type regular is an inference from that absence.[7]

How it works

The label says cabazitaxel binds to tubulin and promotes its assembly into microtubules while inhibiting their disassembly. This stabilises the microtubules and inhibits mitotic and interphase cellular functions.[1]

Where it came from and why

A 2013 preclinical paper describes cabazitaxel as a semisynthetic taxane developed to overcome taxane resistance, about 10-fold more potent than docetaxel in chemotherapy-resistant tumour cells. A 2009 phase I report describes a new taxane with low affinity for the multidrug resistance 1 protein.

Cancers

Family and partners

Derived from: Paclitaxel

Worth knowing

  • A summary of the EMA's scientific review says that in the main study cabazitaxel was associated with a 2.4-month longer median overall survival and a 30% lower risk of death than mitoxantrone.[10]
  • In chemotherapy-resistant tumour cells the IC50 of cabazitaxel ranged from 0.013 to 0.414 micromoles per litre, against 0.17 to 4.01 for docetaxel.[3]
  • In the phase I study of 25 patients the recommended phase II dose on a 1-hour, 3-weekly schedule was 20 mg/m2; partial responses were seen in two patients with metastatic prostate carcinoma.[4]
  • Wani and Horwitz name Taxotere and cabazitaxel as the two semisynthetic molecules derived from Taxol that are approved by the FDA.[5]

On this site

References

  1. Sanofi-Aventis U.S. LLC. Jevtana (cabazitaxel) injection: prescribing information. DailyMed, set ID de3d9c26-572b-4ea4-9b2d-dd58a2b3e8fa, published 27 November 2025. Source
  2. Attard G, Greystoke A, Kaye S, De Bono J. Update on tubulin-binding agents. Pathol Biol (Paris). 2006;54(2):72-84. PubMedDOI
  3. Vrignaud P, Sémiond D, Lejeune P, Bouchard H, Calvet L, Combeau C, et al. Preclinical antitumor activity of cabazitaxel, a semisynthetic taxane active in taxane-resistant tumors. Clin Cancer Res. 2013;19(11):2973-83. PubMedDOI
  4. Mita AC, Denis LJ, Rowinsky EK, Debono JS, Goetz AD, Ochoa L, et al. Phase I and pharmacokinetic study of XRP6258 (RPR 116258A), a novel taxane, administered as a 1-hour infusion every 3 weeks in patients with advanced solid tumors. Clin Cancer Res. 2009;15(2):723-30. PubMedDOI
  5. Wani MC, Horwitz SB. Nature as a remarkable chemist: a personal story of the discovery and development of Taxol. Anticancer Drugs. 2014;25(5):482-7. PubMedDOI
  6. US Food and Drug Administration. NDA approval letter, Jevtana (cabazitaxel) injection, NDA 201023, sanofi-aventis U.S.; electronic signature dated 06/17/2010. Source
  7. European Medicines Agency. Jevtana (cabazitaxel): EPAR product page (EMEA/H/C/002018); page shows last update 20 October 2026. Read 2026-10-29. Source
  8. de Bono JS, Oudard S, Ozguroglu M, Hansen S, Machiels JP, Kocak I, et al. Prednisone plus cabazitaxel or mitoxantrone for metastatic castration-resistant prostate cancer progressing after docetaxel treatment: a randomised open-label trial. Lancet. 2010;376(9747):1147-54. PubMedDOI
  9. Pivot X, Koralewski P, Hidalgo JL, Chan A, Gonçalves A, Schwartsmann G, et al. A multicenter phase II study of XRP6258 administered as a 1-h i.v. infusion every 3 weeks in taxane-resistant metastatic breast cancer patients. Ann Oncol. 2008;19(9):1547-52. PubMedDOI
  10. Pean E, Demolis P, Moreau A, Hemmings RJ, O'Connor D, Brown D, et al. The European Medicines Agency review of cabazitaxel (Jevtana®) for the treatment of hormone-refractory metastatic prostate cancer: summary of the scientific assessment of the committee for medicinal products for human use. Oncologist. 2012;17(4):543-9. PubMedDOI