Janssen has submitted a New Drug Application (NDA) to the US FDA for apalutamide, an investigational, next-gen oral androgen receptor inhibitor for men with non-metastatic castration-resistant prostate cancer (CRPC).
Currently, there are no FDA approved treatments for patients with non-metastatic CRPC.
The submission is based on Phase 3 data from the pivotal ARN-509-003 (SPARTAN) clinical trial.
The trial assessed the safety and efficacy of apalutamide versus placebo in men with non-metastatic CRPC who have a rapidly rising prostate specific antigen despite receiving continuous androgen deprivation therapy.
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 randomisation to first evidence of confirmed metastasis, or time to death.
“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.
After skin cancer, prostate cancer is the most common cancer among American men.
According to the American Cancer Society, more than 161,000 men are estimated to be diagnosed with prostate cancer in 2017.