FDA approves chemotherapy agent for advanced prostate Ca

July 15, 2010

FDA has approved cabazitaxel (Jevtana), a chemotherapeutic agent used in combination with prednisone for treatment of advanced, hormone-refractory prostate cancer following docetaxel (Taxotere)-based treatment.

FDA has approved cabazitaxel (Jevtana), a chemotherapeutic agent used in combination with prednisone for treatment of advanced, hormone-refractory prostate cancer following docetaxel (Taxotere)-based treatment.

FDA evaluated the drug through its priority review program, a 6-month expedited review process for drugs with the possibility of treatment advances.

Drug efficacy and safety were proven in a phase III clinical study involving 755 patients. Investigators found that median overall survival for men taking cabazitaxel with prednisone was 15.1 months, compared with 12.7 months for those taking mitoxantrone (Novantrone) in combination with prednisone.

"With the approval of Jevtana, health care professionals now have a new treatment option for patients with the most advanced stage of prostate cancer and for whom there have been few options," said Oliver Sartor, MD, principal investigator of the phase III clinical study.

The drug is expected to be available in the U.S. this summer, according to sanofi-aventis, its manufacturer.

Dr. Sartor and co-authors of the study disclosed financial interest or other relationship with sanofi-aventis.