The FDA has approved the use of cabazitaxel (Jevtana) in combination with prednisone for the treatment of men with metastatic hormone-refractory prostate cancer who have been previously treated with a docetaxel-containing treatment regimen.
Reviewed under the FDA's priority review program, which provides for an expedited six-month review for drugs that may offer major treatment advances, or provide treatment when no adequate therapy exists, cabazitaxel received approval more than three months ahead of its Sept. 30, 2010 goal date.
Approval of the drug, manufactured by Sanofi-aventis, was based on results from the Phase 3 TROPIC (Treatment of Hormone-Refractory Metastatic Prostate Cancer Previously Treated with a Taxotere-Containing Regimen) study of 755 patients.
Compared with an active chemotherapy regimen consisting of a standard dose of mitoxantrone and prednisone, treatment with cabazitaxel, in combination with prednisone, resulted in a 30% reduction in risk of death for such patients. 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.