FDA Grants Janssen Biotech’s Apalutamide Priority Review Designation to Treat Non-metastatic CRPC

FDA Grants Janssen Biotech’s Apalutamide Priority Review Designation to Treat Non-metastatic CRPC
The U.S. Food and Drug Administration (FDA) has granted priority review status to apalutamide — an investigational androgen receptor inhibitor — to treat men with non-metastatic castration-resistant prostate cancer (CRPC). This new designation will expedite the regulatory review of apalutamide’s New Drug Application (NDA) in six months, compared to 10 months for the standard review. Janssen Biotech,

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