Abiraterone FDA-Approved for Late-Stage Castration-Resistant Prostate Cancer

TON - Daily

The US Food and Drug Administration (FDA) approved abiraterone acetate (Zytiga, Centocor Ortho Biotech) in combination with prednisone to treat patients with metastatic castration-resistant prostate cancer who have received prior docetaxel-based chemotherapy.

 

This oral oncolytic targets CYP 17A1, which plays an important role in the production of testosterone. The drug works by decreasing the production of this hormone that would stimulate cancer cells to continue growing.

 

Under the priority review program, the FDA approved abiraterone based on study of 1195 patients with late-stage castration-resistant prostate cancer (CRPC) who had received prior treatment with docetaxel chemotherapy. Patients received either abiraterone once daily in combination with prednisone two times a day, or a placebo twice daily in combination with prednisone. Patients in the abiraterone arm achieved a median overall survival of 14.8 months compared with 10.9 months for patients receiving the placebo.

 

The most commonly reported side effects 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.

 

Read the FDA Press Release:

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm253055.htm

 

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