Pharmaceutical company Astellas Pharma Inc (TSE:4503) reported on Monday the receipt of the priority review designation from the US Food and Drug Administration (FDA) for its supplemental New Drug Application (sNDA) for XTANDI (enzalutamide) for non-metastatic castration-resistant prostate cancer.

The company said the Prescription Drug User Fee Act (PDUFA) goal date assigned by the US FDA is July 2018. The European Medicines Agency has validated the Type II Variation submitted for XTANDI seeking to expand the current indication to the same patient population and started the review process in March.

Upon approval by the US FDA, the sNDA would expand the indication of XTANDI to include men with non-metastatic Castration-Resistant Prostate Cancer (CRPC), based on data from the company's Phase 3 PROSPER trial. XTANDI is currently indicated for the treatment of patients with metastatic CRPC.

The PROSPER trial evaluated XTANDI plus androgen deprivation therapy (ADT) versus ADT alone in 1,401 patients with non-metastatic CRPC. The study met its primary endpoint, demonstrating that the use of XTANDI plus ADT significantly reduced the risk of developing metastasis or death compared to ADT alone.

According to the company, XTANDI (enzalutamide) is an androgen receptor inhibitor indicated for the treatment of patients with metastatic castration-resistant prostate cancer, which refers to the subset of men whose prostate cancer progresses despite castration levels of testosterone.