The U.S. Food and Drug Administration has granted Priority Review designation for Janssen Biotech’s New Drug Application (NDA) for apalutamide, an investigational, next-generation oral androgen receptor (AR) inhibitor for the treatment of men with non-metastatic castration-resistant prostate cancer (CRPC). Currently, there are no FDA-approved treatments for patients with non-metastatic CRPC.

“The prognosis for men with prostate cancer is significantly worse once the cancer has spread to other parts of the body. Accordingly, men with non-metastatic castration-resistant prostate cancer need treatment options that can delay disease progression and improve long-term outcomes,” said Craig Tendler, M.D., vice president of Late Development and Global Medical Affairs, Oncology at Janssen. “We are encouraged by the FDA’s recognition, via the priority review designation, of the potential for apalutamide to provide such an option for these men.”

The NDA submission for apalutamide, which was completed on October 10, 2017, was 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). 

The SPARTAN study results have been accepted for oral presentation at the ASCO Genitourinary Cancers Symposium on Thursday, February 8, 2018, in San Francisco.