Enzalutamide to treat mCSPCFebruary 6, 2020
Pfizer and Astellas Pharma announced that the US FDA has approved a supplemental New Drug Application (sNDA) for enzalutamide (Xtandi) for the treatment of patients with metastatic castration-sensitive prostate cancer (mCSPC).
With this approval, enzalutamide is now the first and only oral treatment approved by the FDA in three distinct types of advanced prostate cancer – non-metastatic and metastatic castration-resistant prostate cancer (CRPC) and mCSPC.
The approval is based on results from ARCHES, a randomised phase 3 study which evaluated 1,150 men with mCSPC and met its primary endpoint of radiographic progression-free survival (rPFS).
Data from the ARCHES trial demonstrated that the use of enzalutamide plus androgen deprivation therapy (ADT) significantly reduced the risk of radiographic progression or death by 61 percent compared to placebo plus ADT (n=1,150; hazard ratio [HR]: 0.39 [95% confidence interval (CI): 0.30-0.50]; p<0.0001). Overall survival data were not mature at the time of final rPFS analysis.
Enzalutamide is an androgen receptor inhibitor.