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Janssen Submits New Drug Application to U.S. FDA for Apalutamide (ARN-509)

Janssen Biotech, Inc. has announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Apalutamide, an investigational, next-generation oral androgen receptor (AR) inhibitor for men with non-metastatic castration-resistant prostate cancer (CRPC).

Currently, there are no FDA approved treatments for patients with non-metastatic CRPC.

This submission is based on Phase 3 data from the pivotal ARN-509-003 (SPARTAN) 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).1 MFS is the time from randomisation to first evidence of confirmed metastasis or time to death. The SPARTAN study results will be presented at a future medical meeting.

"The SPARTAN data lead the path towards a new approach to treating men with prostate cancer earlier in the disease course. We have demonstrated that treating patients before the disease has metastasised improves outcomes," said Peter Lebowitz, M.D., Ph.D., Global Therapeutic Area Head of Oncology at Janssen. "We are thrilled to have completed our submission of the SPARTAN data to the FDA and we look forward to a promising treatment that can provide new hope and expectations for men facing this disease."

Prostate cancer is the most common cancer among American men, other than skin cancer. According to the American Cancer Society, more than 161,000 men are estimated to be diagnosed with prostate cancer in 2017. Patients with non-metastatic prostate cancer receiving ADT will eventually become resistant to ADT, developing castration-resistant prostate cancer (CRPC). Data has estimated 10% to 20% of patients diagnosed with prostate cancer may develop CRPC within approximately 5 years.

Non-metastatic castration-resistant prostate cancer refers to patients with CRPC who lack detectable distant metastatic disease. These individuals have a rising PSA, testosterone level below 50 ng/dl and bone scan and CT scans that show no evidence of spread to bones or visceral organs. Men with rapidly rising PSA have a high unmet medical need, as these patients are at high risk for developing metastatic disease.