Journal
ONCOLOGIST
Volume 17, Issue 4, Pages 543-549Publisher
ALPHAMED PRESS
DOI: 10.1634/theoncologist.2011-0364
Keywords
Cabazitaxel; Jevtana; Hormone-refractory metastatic prostate cancer; EMA; European Medicines Agency
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On March 17, 2011 the European Commission issued a marketing authorization valid throughout the European Union for Jevtana (R) (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 (R) is cabazitaxel acetone solvate, an antineoplastic agent that acts by disrupting the microtubular network in cells. The recommended dose of cabazitaxel is 25 mg/m(2) 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). The Oncologist 2012;17:543-549
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