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Company Docetaxel Subgroup / AEs / ITT / Autologous Cellular Immunotherapy Dendreon Corporation / Cox / / Country United States / / Currency pence / / Event FDA Phase / / Facility Laboratory Findings / / IndustryTerm therapies for metastatic prostate cancer / cancer therapy / treatment of symptomatic bone disease / therapies for prostate cancer / / MedicalCondition recurrent prostate cancer / metastatic prostate cancer / headache / Acute Cardiac Arrhythmias / mild cancer / nausea / objective disease / metastatic disease / fatigue / independent prostate cancer / tachycardia / resistant prostate cancer / Prostate Cancer / transient ischemic attacks / back pain / hypertension / bronchospasm / cancer / disease / sensitive prostate cancer / arthralgia / additional cancer / dyspnea / pyrexia / back pain / chills / symptomatic bone disease / independent prostate adenocarcinoma / progressive metastatic prostate cancer / bone metastases / fever / vomiting / pain / metastases / paresthesia / / MedicalTreatment salvage therapy / Leukapheresis / intravenous infusions / chemotherapy / radiation / cancer therapy / leukaphereses / / MusicGroup Ph.D. / / Organization PDUFA Goal Date Division / office of Biostatistics and Epidemiology / FDA Cell Tissue and Gene Therapy Advisory Committee / Division of Clinical Evaluation and Pharmacology / Team Leader Branch Chief Office / FDA / A. Advisory Committee / Toxicology Office / / Person M.D. Peter Bross / M.D. Celia Witten / Bindu George / Chaohong Fan / D. Wilson W. Bryan / / Position Director Review Completion Date / Major / / Product Estradiol / Autologous Cellular Immunotherapy Dendreon Corporation Cell suspension / prednisone / mitoxantrone / D9902B / D9901 / APC8015F / Cell / Anthracenedione Zolendronic acid / D9902A / / Technology radiation / 89 C. Protocol / Gene Therapy / chemotherapy / treating cancer / / SocialTag 
CDER Clinical Review Template