TOKYO - Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., 'Astellas') today announced that the China National Medical Products Administration (NMPA) has approved XTANDI (enzalutamide soft capsules) for the treatment of adult men with non-metastatic castration-resistant prostate cancer (nmCRPC) with high risk of metastasis.
This is the second approved indication in China for enzalutamide, which is already available for adult men with metastatic castration-resistant prostate cancer (mCRPC) who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy (ADT), in whom chemotherapy is not yet indicated.
The approval is based on results from the PROSPER trial, a double-blind, placebo-controlled, pivotal Phase 3 trial that evaluated enzalutamide plus ADT versus placebo plus ADT in 1,401 men with nmCRPC and rapidly rising prostate-specific antigen levels. PROSPER met its primary endpoint of metastasis-free survival (MFS), with a median MFS of 36.6 months for men who received enzalutamide plus ADT, compared to 14.7 months with placebo plus ADT. Results demonstrated a 71 percent reduction in the risk of radiographic progression or death in men who received enzalutamide plus ADT, compared to placebo plus ADT (hazard ratio=0.29 [95% confidence interval: 0.24-0.35]; p
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