U.S. Food and Drug Administration Approval Summary: Enzalutamide for the Treatment of Patients With Chemotherapy-Naïve Metastatic Castration-Resistant Prostate Cancer.

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Published in Oncologist on June 12, 2015

Authors

Yang-Min Ning1, Michael Brave2, V Ellen Maher2, Lijun Zhang2, Shenghui Tang2, Rajeshwari Sridhara2, Geoffrey Kim2, Amna Ibrahim2, Richard Pazdur2

Author Affiliations

1: Office of Hematology and Oncology Products, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA ningy@cder.fda.gov.
2: Office of Hematology and Oncology Products, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA.

Associated clinical trials:

A Safety and Efficacy Study of Oral MDV3100 in Chemotherapy-Naive Patients With Progressive Metastatic Prostate Cancer (PREVAIL) | NCT01212991

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