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NOVEMBER 21, 2023

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


Originally published by our sister publication Clinical Oncology News

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