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FDA Approves Reduced Dose of Cabazitaxel for mCRPC

Jason Harris
Published: Monday, Sep 18, 2017

The FDA has approved a cabazitaxel (Jevtana) regimen of 20 mg/m2 every 3 weeks in combination with prednisone for the treatment of men with metastatic castration-resistant prostate cancer who previously received a docetaxel-containing regimen. The agency approved a dose of 25 mg/m2 every 3 weeks in this patient population in 2010.

Deaths within 30 days of the last study drug dose (5.4% vs 3.8%), and early infection-related deaths within 30 days of the treatment initiation (1.3% vs 0.7%) were more common in the C25 arm. All of the early infection-related deaths occurred in patients older than 60 years of age.
Eisenberger M, Hardy-Bessard A, Kim CS, et a. Phase III study comparing a reduced dose of cabazitaxel (20 mg/m2) and the currently approved dose (25 mg/m2) in postdocetaxel patients with metastatic castration-resistant prostate cancer—PROSELICA [published online ahead of print August 15, 2017]. J Clin Oncol. doi: 10.1200/JCO.2017.74.7931.

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