Pharmaceutical company Astellas Pharma Inc (TSE:4503) and Pfizer Inc (NYSE:PFE) reported on Friday the receipt of approval from the US Food and Drug Administration (FDA) for a supplemental New Drug Application (sNDA) for XTANDI (enzalutamide) for the treatment of prostrate cancer.

In 2012, XTANDI was first approved by the US FDA for treating patients with metastatic CRPC who had previously received docetaxel and was granted approval in 2014 for chemotherapy-naïve men with metastatic CRPC. Prostate cancer is the second most common cancer in men, added the company.

Following the US FDA priority review approval, XTANDI is the first and only oral medication US FDA-approved for both non-metastatic and metastatic CRPC.

Under the Phase 3 PROSPER trial, the company enrolled 1,401 patients with non-metastatic CRPC. Patients were randomized 2:1 and received either XTANDI plus ADT or placebo plus ADT. The median for the primary endpoint was 36.6 months for men who received XTANDI over 14.7 months with ADT alone.

The company said the updated label is based on results from the Phase 3 PROSPER trial, which demonstrated that the use of XTANDI plus androgen deprivation therapy (ADT) significantly reduced the risk of developing metastasis or death compared to ADT alone in men with non-metastatic CRPC.

According to the company, the data from the PROSPER study were presented at the 2018 Genitourinary Cancers Symposium (ASCO GU) in February and published in the New England Journal of Medicine in June.