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.
Author(s): Pean E, Demolis P, Moreau A, Hemmings RJ, O'Connor D, Brown D, Shepard T, Abadie
E, Pignatti F.
Affiliation(s): European Medicines Agency, 7 Westferry Circus, London E14 4HB, UK.
Elias.Pean@ema.europa.eu
Publication date & source: 2012, Oncologist. , 17(4):543-9
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).
|