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EMA’s CHMP recommended approval of Xtandi for castration sensitive prostate cancer
The EMA’s CHMP has recommended approval of enzalutamide (Xtandi) for the treatment of adult men with metastatic castration-sensitive prostate cancer.
The CHMP based its recommendation on data from the Phase 3 ARCHES trial, in which the median radiographic progression-free survival in men with mCRPC was not reached with enzalutamide plus androgen deprivation therapy and was 19.45 months with placebo and ADT, translating to a 61% reduction in risk of radiographic progression or death with enzalutamide.
