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FDA Approves Enzalutamide for nmCSPC With High-Risk Biochemical Recurrence

The FDA has approved enzalutamide for the treatment of patients with nonmetastatic castration-sensitive prostate cancer with biochemical recurrence at high risk for metastasis. ....

Almeida Luz , Ahsan Arozullah , Astella Xtandi , Oncology Development At Astellas , Oncology Development , Nonmetastatic Castration Sensitive Prostate Cancer , Prostate Cancer ,

EMA Validates Type II Variation Application for Enzalutamide in Nonmetastatic Hormone-Sensitive Prostate Cancer

The European Medicines Agency has validated its Type II variation for enzalutamide as an option in patients with nonmetastatic hormone-sensitive prostate cancer at high risk of biochemical recurrence who are not suitable for salvage radiotherapy. ....

United States , Ahsan Arozullah , Astella Xtandi , Almeida Luz , Oncology Department At Astellas Pharma Inc , European Medicines Agency , European Union , Astellas Pharma Inc , Pfizer Inc , Oncology Department , Astellas Pharma , Medicines Agency , Nonmetastatic Hormone Sensitive Prostate Cancer ,

FDA Grants Priority Review to Enzalutamide for nmCSPC With High-Risk Biochemical Recurrence

The FDA has accepted and granted priority review to a supplemental new drug application seeking the approval of enzalutamide in patients with nonmetastatic castration-sensitive prostate cancer with high-risk biochemical recurrence. ....

United States , Almeida Luz , Chris Boshoff , Pfizer Inc , Astellas Pharma Inc , Prescription Drug User Fee Act , Astellas Pharma , Prostate Cancer , Nonmetastatic Castration Sensitive Prostate Cancer ,