=Johnson & Johnson's (JNJ): Janssen submits a New Drug Application to the FDA for apalutamide

Johnson & Johnson's Janssen submits a New Drug Application to the FDA for apalutamide, an investigational, next generation oral androgen receptor inhibitor for men with non-metastatic castration-resistant prostate cancer

• Currently, there are no FDA approved treatments for patients with non-metastatic castration-resistant prostate cancer (CRPC).
• This submission is based on Phase 3 data from the pivotal ARN-509-003 clinical trial, which assessed the safety and efficacy of apalutamide versus placebo, in men with non-metastatic CRPC who have a rapidly rising prostate specific antigen (PSA) despite receiving continuous androgen deprivation therapy (ADT). Men with non-metastatic CRPC with a rapidly rising PSA are at high risk for developing metastatic disease.
• The primary endpoint of this study was metastasis free survival (MFS). MFS is the time from randomization to first evidence of confirmed metastasis, or time to death.
• The SPARTAN study results will be presented at a future medical meeting.