title: 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.
abstract: On March 17, 2011 the European Commission issued a marketing authorization valid throughout the European Union for Jevtana® (Sanofi-Aventis, Paris, France) for the treatment of patients with hormone-refractory metastatic prostate cancer previously treated with a docetaxel-containing regimen. The active substance of Jevtana® is cabazitaxel acetone solvate, an antineoplastic agent that acts by disrupting the microtubular network in cells. The recommended dose of cabazitaxel is 25 mg/m2 administered as a 1-hour i.v. infusion every 3 weeks in combination with oral prednisone or prednisolone, 10 mg, administered daily throughout treatment. In the main study submitted for this application, a 2.4-month longer median overall survival time and a 30% lower risk for death were observed for cabazitaxel, compared with mitoxantrone. The most common side effects with cabazitaxel were anemia, leukopenia, neutropenia, thrombocytopenia, and diarrhea. This paper summarizes the scientific review of the application leading to approval in the European Union. The detailed scientific assessment report and product information, including the summary of product characteristics, are available on the European Medicines Agency Web site (http://www.ema.europa.eu).
authors.affiliation: European Medicines Agency, 7 Westferry Circus, London E14 4HB, UK. Elias.Pean@ema.europa.eu
authors.forename: Elias
authors.initials: E
authors.lastname: Pean
authors.forename: Pierre
authors.initials: P
authors.lastname: Demolis
authors.forename: Alexandre
authors.initials: A
authors.lastname: Moreau
authors.forename: Robert James
authors.initials: RJ
authors.lastname: Hemmings
authors.forename: Daniel
authors.initials: D
authors.lastname: O'Connor
authors.forename: David
authors.initials: D
authors.lastname: Brown
authors.forename: Terry
authors.initials: T
authors.lastname: Shepard
authors.forename: Eric
authors.initials: E
authors.lastname: Abadie
authors.forename: Francesco
authors.initials: F
authors.lastname: Pignatti
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000493:pharmacokinetics / Q000494:pharmacology / Q000627:therapeutic use; D017326:Clinical Trials, Phase III as Topic; D017277:Drug Approval; D064420:Drug-Related Side Effects and Adverse Reactions; D005062:European Union; D006801:Humans; D008297:Male; D008875:Middle Aged; D009376:Neoplasms, Hormone-Dependent / Q000188:drug therapy / Q000378:metabolism; D011471:Prostatic Neoplasms / Q000188:drug therapy* / Q000378:metabolism; D016032:Randomized Controlled Trials as Topic; D015996:Survival Rate; D043823:Taxoids / Q000009:adverse effects* / Q000493:pharmacokinetics / Q000494:pharmacology / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D043823:Taxoids; C552428:cabazitaxel