FDA approved use of Zytiga prior to chemotherapy
The FDA recently approved abiraterone acetate, a drug that decreases the production of testosterone, for use in treating men with metastatic castration-resistant prostate cancer prior to receiving chemotherapy.
The FDA initially approved abiraterone acetate in April 2011 for use in patients whose prostate cancer progressed after treatment with docetaxel.
“[This] approval demonstrates the benefit of further evaluating a drug in an earlier disease setting and provides patients and healthcare providers the option of using Zytiga earlier in the course of treatment,” said Richard Pazdur, MD, director of the Office of Oncology Drug Products in the FDA’s Center for Drug Evaluation and Research.
The safety and effectiveness of the expanded use of abiraterone acetate were established in a clinical study of 1088 men with late-stage, castration-resistant prostate cancer who had not previously received chemotherapy.
The study was designed to measure overall survival time and radiographic progression-free survival (rPFS). Participants received prednisone in combination with either abiraterone acetate or a placebo.
Those who received abiraterone acetate had a median overall survival of 35.3 months compared with 30.1 months for patients receiving the placebo. Abiraterone acetate also improved rPFS, according to study results. At the time of analysis, the median rPFS was 8.3 months in the placebo group, and the median had not yet been reached for patients treated with abiraterone acetate.
Those receiving abiraterone acetate reported the following side effects most often: fatigue, joint swelling or discomfort, swelling caused by fluid retention, hot flush, diarrhea, vomiting, cough, high blood pressure, shortness of breath, urinary tract infection, and bruising.
Laboratory abnormalities included: low red blood cell count; high levels of the enzyme alkaline phosphatase; high levels of fatty acids, sugar, and liver enzymes in the blood; and low levels of lymphocytes, phosphorous, and potassium in the blood.
Source: FDA.