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City Docetaxel / / Company Subgroup 2 (enzalutamide only) AB / AEs / New England Journal / HR (95% CI) Ind. / GE / Astellas Pharma Australia Pty Ltd / ITT / / Country Australia / / Event FDA Phase / Product Issues / Product Recall / / Facility Consumer Comments facility / / IndustryTerm treatment of patients with mCRPC whose disease / treatment of metastatic prostate cancer / treatment of metastatic castration-resistant prostate cancer / prescription processing / treatment algorithm / / MedicalCondition insomnia / metastatic prostate cancer / earlier disease / hypertension / cancer / resistant metastatic carcinoma / disease / headache / castration-resistant prostate cancer / seizures / mCRPC whose disease / progressive disease / carcinoma / end-stage disease / mutated androgen-receptor causing disease / metastatic castration-resistant prostate cancer / pain / fatigue / skeletal metastases / earlier stage disease / prostate cancer / resistant prostate cancer / / MedicalTreatment chemotherapy / oral therapy / / Organization World Health Organization / Data Monitoring Committee / Clinical Review Centre / FDA / Statistical Review Centre / Application Authority / / Person Max Qty / / Position Governor / Minister / nurse / General / / Product prednisolone / Manufacturer Enzalutamide Capsules / severity necessitating permanent treatment / flutamide / bicalutamide / prednisone / 202379Orig1s000StatR / NCT01798615 / enzalutamide / 202379Orig1s000PharmR / ABI-301 / / ProvinceOrState Indiana / / PublishedMedium the New England Journal of Medicine / Journal of Clinical Oncology / / Region New England / / Technology treatment algorithm / submission Trial ID Protocol / chemotherapy / pdf / / URL www.msac.gov.au / http / SocialTag 
5.5 ENZALUTAMIDE, capsule, 40 mg, Xtandi®, Astellas Pharma Australia Pty Ltd, Purpose of Application Authority required (Streamlined) listing for enzalutamide for treatment of metastatic prostate cancer after treatment