Published on June 18, 2010 at 12:34 AM
Jevtana's safety and effectiveness was established in a single, 755-patient study. All study participants had previously received docetaxel. The study was designed to measure overall survival (the length of time before death) in men who received Jevtana in combination with prednisone compared with those who received the chemotherapy drug, mitoxantrone, in combination with prednisone. The median overall survival for patients receiving the Jevtana regimen was 15.1 months compared with 12.7 months for those who received the mitoxantrone regimen.
Side effects in those treated with Jevtana included decrease in infection-fighting white blood cells (neutropenia), anemia, decrease in the number of white blood cells (leukopenia), low level of platelets in the blood (thrombocytopenia), diarrhea, fatigue, nausea, vomiting, constipation, weakness (asthenia), and renal failure.
Prostate cancer, which usually occurs in older men, is the second most common cancer among men in the United States, behind skin cancer. In 2006, the most recent year for which numbers were available, 203,415 men developed prostate cancer and 28,372 men died from the disease, according to the Centers for Disease Control and Prevention.
Jevtana is marketed by Bridgewater, N.J.-based Sanofi-Aventis.http://www.fda.gov