Sanofi-aventis announced that the FDA has approved Jevtana (cabazitaxel injection) in combination with prednisone for the treatment of patients with metastatic hormone-refractory prostate cancer (mHRPC) previously treated with a docetaxel-containing treatment regimen. This approval was based on results from the Phase 3 TROPIC clinical study involving 755 patients with mHRPC previously treated with a docetaxel-containing treatment regimen. Results from this trial demonstrated a statistically significant 30% [HR=0.70 (95% CI: 0.59-0.83); P<0.0001] reduction in risk of death from mHRPC among patients taking Jevtana in combination with prednisone compared with an active chemotherapy regimen consisting of a standard dose of mitoxantrone and prednisone. Investigator-assessed tumor response rates using Response Evaluation Criteria in Solid Tumors (RECIST) were 14.4% and 4.4% for cabazitaxel-treated and mitoxantrone-treated patients respectively, p=0.0005.

Jevtana is a microtubule inhibitor designed to be administered intravenously.  It is expected to be available in the U.S. this summer.  

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