Janssen have submitted a New Drug Application (NDA) for apalutamide (ARN-509), intended to treat men with non-metastatic castration-resistant prostate cancer (CRPC).

Apalutamide, an investigational, next generation oral androgen receptor inhibitor, was assessed for safety and efficacy in the Phase 3 pivotal trial, ARN-509-003 (SPARTAN), which the NDA is based on. A total of 1,200 men with non-metastatic CRPC who had rapidly rising prostate specific antigen (PSA) despite receiving continuous androgen deprivation therapy, were included. 

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The participants were randomized to either a once daily dose regimen of 240mg of apalutamide or placebo, and were followed until development of metastasis, death, or up to study duration of 65 months. The primary outcome is metastasis-free survival. Primary completion was on May 19, 2017, however, study results have not yet been released. The company stated in a press release that the results will be announced at a future medical meeting.

There is currently no FDA-approved treatment for patients with non-metastatic CRPC.  “We are thrilled to have completed our submission of the SPARTAN data to the FDA,” said Peter Lebowitz, MD, PhD, Global Therapeutic Area Head of Oncology at Janssen. “We look forward to a promising treatment that can provide new hope and expectations for men facing this disease.”

For more information visit Janssen.com.