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FDA Approves New Drug Application for Enzalutamide in Earlier Prostate Cancer Setting
The US Food and Drug Administration (FDA) has approved a supplemental New Drug Application for enzalutamide (XTANDI) as the first androgen receptor signaling inhibitor for the treatment of non-metastatic castration-sensitive prostate cancer (nmCSPC) with biochemical recurrence at high risk for metastasis (high-risk BCR). With this approval, patients with nmCSPC and high-risk BCR may now be treated with enzalutamide with or without a gonadotropin-releasing hormone (GnRH) analog therapy. ...
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