Janssen Seeks Approval of Apalutamide for Non-metastatic Castration-resistant Prostate Cancer

Janssen Seeks Approval of Apalutamide for Non-metastatic Castration-resistant Prostate Cancer
Janssen Biotech has submitted a new drug application  to the U.S. Food and Drug Administration (FDA) for an investigational, next-generation therapy called apalutamide (ARN-509) to treat non-metastatic castration-resistant prostate cancer. Apalutamide is an oral androgen receptor inhibitor that blocks the action of testosterone in prostate cancer cells. The submission was based on data from the Phase 3 SPARTAN clinical trial (NCT01946204), an ongoing study of the safety and efficacy of apalutamide versus placebo, in men with non-metastatic castration-resistan
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