On June 17, 2010, the U.S. Food and Drug Administration (FDA) approved cabazitaxel (Jevtana® Injection, sanofi-aventis) for use in combination with prednisone for treatment of patients with metastatic hormone-refractory prostate cancer (mHRPC) previously treated with a docetaxel-containing regimen.

The approval is based primarily on the results of a randomized, open-label, international trial of 755 patients with mHRPC previously treated with docetaxel-containing regimens.  Patients were randomized to receive either cabazitaxel 25 mg/m2 intravenously every three weeks in combination with prednisone 10 mg/day or mitoxantrone 12 mg/m2 intravenously every three weeks in combination with prednisone 10 mg/day.   Patients were treated until disease progression, death, unacceptable toxicity, or completion of 10 cycles of therapy.

Median survivals were 15.1 and 12.7 months for cabazitaxel-treated and mitoxantrone-treated patients, respectively [HR 0.70 (95% CI 0.59-0.83), p<0.0001.] …  No complete responses were observed on either arm.

Please view the full FDA announcement for details of adverse reactions and prophylactic treatments: http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm216214.htm  

Full prescribing information, including clinical trial information, safety, dosing, drug-drug interactions and contraindications is available at:  http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/201023lbl.pdf