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news.The US Food and Drug Administration (FDA) has approved Centocor Ortho Biotech’s ZYTIGA (abiraterone acetate), an oral, medication used in combination with prednisone for the treatment of men with metastatic castration-resistant prostate cancer who have received prior chemotherapy containing docetaxel.
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ZYTIGA is an oral androgen biosynthesis inhibitor that inhibits androgen producing CYP17 enzyme complex.
According to a randomized, placebo-controlled Phase 3 study treatment with ZYTIGA in combination with prednisone resulted in a 35% reduction in the risk of death.
In an updated analysis, results were consistent with those from the interim analysis with a 4.6 month difference between the two arms in median survival (15.8 months vs. 11.2 months [HR = 0.74]).
Memorial Sloan-Kettering Sidney Kimmel Center for Urologic and Prostate Cancers Genitourinary Oncology Service chief Howard Scher said the efficacy and safety profile of abiraterone acetate, as well as its oral, once-daily formulation, promises a new option in the treatment of metastatic prostate cancer.