Janssen Biotech submits NDA to FDA for apalutamide to treat non-metastatic CRPC


Janssen Biotech has submitted a new drug application (NDA) to the US Food and Drug Administration (FDA) for apalutamide to treat male patients with non-metastatic castration-resistant prostate cancer (CRPC).

Apalutamide is a new investigational, oral androgen receptor (AR) inhibitor that inhibits the action of testosterone in prostate cancer cells and works by preventing androgen from binding to the androgen receptor.

Patients with non-metastatic CRPC lack detectable distant metastatic disease.

Janssen’s NDA submission for apalutamide is based on data obtained from the pivotal Phase III ARN-509-003 (SPARTAN) trial.

The trial evaluated 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).

"The SPARTAN data lead the path towards a new approach to treating men with prostate cancer earlier in the disease course."

Patients with non-metastatic prostate cancer receiving ADT eventually becomes resistant to it, thereby developing CRPC.

Janssen Biotech Oncology Global Therapeutic Area head Dr Peter Lebowitz said: “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 metastasized improves outcomes.

“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.”

There are currently no FDA approved treatments for patients with non-metastatic CRPC.