FDA shares data from first drug in transparency pilot

As part of its clinical data transparency pilot program, FDA posted on Monday a clinical study report for Erleada apalutamide from the Janssen Biotech Inc. unit of Johnson & Johnson (NYSE:JNJ).

The report contains extensive data and trial information from the Phase III SPARTAN study of the second-generation androgen receptor antagonist, which the agency approved in February to treat non-metastatic castration-resistant prostate cancer. ...