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

Learning Objectives: After completing this course, the reader will be able to: Summarize the efficacy outcomes of cabazitaxel pivotal trials in the treatment of hormone‐refractory metastatic prostate cancer. Describe the safety profile and most common adverse effects of cabazitaxel in patients with hormone‐refractory metastatic prostate cancer. This article is available for continuing medical education credit at CME.TheOncologist.com 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). The scientific review of the application leading to the approval, in the European Union, of cabazitaxel for the treatment of patients with hormone‐refractory metastatic prostate cancer previously treated with a docetaxel‐containing regimen is summarized.