Japan-based Astellas Pharma Inc. (TYO: 4503) has announced that the Center for Drug Evaluation (CDE) has accepted for review the New Drug Application (NDA) for its medication Xtandi (enzalutamide), which is intended for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC).
NDA Basis and Study Results
The NDA is supported by the outcomes of the Phase III China ARCHES study. The study involved 180 Chinese patients with mHSPC in mainland China, who were randomized to receive Xtandi in combination with androgen deprivation therapy (ADT) or a placebo plus ADT. The study successfully met its primary endpoint, showing a statistically significant improvement in time to prostate-specific antigen (PSA) progression (TTPP). This progression is defined as a ≥ 25% increase and an absolute increase of ≥ 2 µg/L (2 ng/mL) above the nadir PSA value, confirmed by a second consecutive value at least 3 weeks later. These results are consistent with those from Astellas’ global Phase III ARCHES study, which targeted the same patient population.
Prostate Cancer in China and Urgent Need for Treatment
Prostate cancer is the most prevalent cancer among the male urogenital system in China, with an increasing incidence. The median survival period for Chinese patients with metastatic hormone-sensitive prostate cancer after receiving androgen deprivation treatment is only 3-4 years, highlighting the urgent need for new treatment options.-Fineline Info & Tech
