U.S. Food and Drug Administration has approved Zytiga (abiraterone acetate) in combination with prednisone (a steroid) to treat patients with late-stage (metastatic) castration-resistant prostate cancer who have received prior docetaxel (chemotherapy).
Abiraterone acetate (CB7630) is an orally administered inhibitor of the steroidal enzyme CYP17 (17α-hydroxylase/C17,20 lyase), a cytochrome p450 complex that is involved in testosterone production and estrogen production Zytiga has been approved ahead of the product’s June 20, 2011 regulatory goal date.
Zytiga’s safety and effectiveness were established in a clinical study of 1,195 patients with late-stage castration-resistant prostate cancer who had received prior treatment with docetaxel chemotherapy. Patients received either Zytiga once daily in combination with prednisone two times a day or a placebo twice daily in combination with prednisone.
The study was designed to measure overall survival, the length of time from when the treatment started until a patient's death. Patients who received the Zytiga and prednisone combination had a median overall survival of 14.8 months compared to 10.9 months for patients receiving the placebo and prednisone combination.
The most commonly reported side effects in patients receiving Zytiga included joint swelling or discomfort, low levels of potassium in the blood, fluid retention (usually of the legs and feet), muscle discomfort, hot flashes, diarrhea, urinary tract infection, cough, high blood pressure, heartbeat disorders, urinary frequency, increased nighttime urination, upset stomach or indigestion and upper respiratory tract infection.
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm253055.htm
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