Prostate drug approved for use in non-metastatic cases

The US Food and Drug Administration has approved the drug Xtandi (enzalutamide) to treat men with advanced non-metastatic prostate cancer. This follows a ‘priority review’ designation, based on the results of a Phase 3 PROSPER trial, which demonstrated that the use of Pfizer and Astellas’s Xtandi plus androgen deprivation therapy (ADT) significantly reduced the risk of developing metastasis or death compared to ADT alone in men with non-metastatic castration-resistant prostate cancer (CRPC). The approval means Xtandi, which is an androgen receptor inhibitor, is the first and only oral medication FDA-approved for both non-metastatic and metastatic CRPC.