FDA Approves Xtandi for Nonmetastatic Castration-Sensitive Prostate Cancer With Biochemical Recurrence

The FDA approved enzalutamide (Xtandi, Astellas Pharma) for nonmetastatic castration-sensitive prostate cancer (nmCSPC) with biochemical recurrence at high risk for metastasis (high-risk BCR).

Efficacy was evaluated in EMBARK (ClinicalTrials.gov Identifier: NCT02319837), a randomized controlled clinical trial of 1,068 patients with nmCSPC with high-risk BCR. All patients had prior definitive therapy with radical prostatectomy and/or radiotherapy with curative intent, had prostate-specific