The FDA has granted a priority review designation to a supplemental new drug application for enzalutamide (Xtandi) for the treatment of men with metastatic hormone-sensitive prostate cancer (mHSPC), according to Astellas Pharma Inc. and Pfizer Inc., the codevelopers of the androgen receptor inhibitor.
The designation, which will expedite the development and review of enzalutamide in this setting, is based on data from the phase III ARCHES and ENZAMET trials. The ARCHES study showed that at a median follow-up of 14.4 months, median radiographic progression-free survival (rPFS) in men with mHSPC was not reached in the enzalutamide arm and was 19.45 months in the placebo arm, translating to a 61% reduction in risk of radiographic progression or death with enzalutamide (HR, 0.39; 95% CI, 0.30-0.50; P
In the phase III ENZAMET trial, the 3-year overall survival (OS) rate in men with mHSPC was 80% in patients treated with enzalutamide plus standard of care (SOC) compared with 72% among those who received a different nonsteroidal antiandrogen (NSAA; HR, 0.67; 95% CI, 0.52-0.86; P
... to read the full story