title: [Abiraterone acetate(ZYTIGA®)-development and literature review].
abstract: Abiraterone acetate(AA)has been approved in more than 80 countries for the treatment of patients with metastatic castration-resistant prostate cancer(mCRPC). In July 2013, a marketing approval application for AA was submitted to the Japanese Ministry of Health, Labour, and Welfare. AA is a selective inhibitor of CYP17A1, a crucial enzyme for androgen biosynthesis. AA exerts its anti-tumor activity by directly inhibiting androgen production at all three sources, i. e., the testes, adrenal glands, and tumor itself. Data from international phase III studies and phase I and II studies in Japan have indicated that AA improves the overall survival and quality of life(QoL)of patients with mCRPC. Herein, we have summarized the development of AA and the results of important international and local clinical trials in Japan. In addition, the effect of food on AA bioavailability, concomitant steroid use, and liver function test abnormalities have been discussed regarding the appropriate use of AA.
authors.affiliation: Division of Medical Affairs,Janssen Pharmaceutical K. K.
authors.forename: Yukiko
authors.initials: Y
authors.lastname: Nishimura
authors.forename: Harumi
authors.initials: H
authors.lastname: Mukai
authors.forename: Kazumi
authors.initials: K
authors.lastname: Suzukawa
authors.forename: Ryo
authors.initials: R
authors.lastname: Oyama
mesh_terms: D000069501:Abiraterone Acetate; D000730:Androstadienes / Q000009:adverse effects / Q000627:therapeutic use*; D000736:Androstenes; D000737:Androstenols / Q000009:adverse effects / Q000627:therapeutic use*; D056486:Chemical and Drug Induced Liver Injury; D002986:Clinical Trials as Topic; D004791:Enzyme Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D064129:Prostatic Neoplasms, Castration-Resistant / Q000188:drug therapy* / Q000201:enzymology; D013254:Steroid 17-alpha-Hydroxylase / Q000037:antagonists & inhibitors*
chemical_list: D000730:Androstadienes; D000736:Androstenes; D000737:Androstenols; D004791:Enzyme Inhibitors; C501892:CYP17A1 protein, human; D013254:Steroid 17-alpha-Hydroxylase; D000069501:Abiraterone Acetate; C089740:abiraterone