Astellas submits prostate cancer drug for EU approval
Japanese drug major Astellas Pharma (TYO: 4503) yesterday filed a marketing authorization application to the European Medicines Agency for enzalutamide (USAN, MDV3100) for the treatment of men with metastatic castration-resistant prostate cancer who have been previously treated with docetaxel-based chemotherapy.
Enzalutamide, is a novel, once-daily investigational oral androgen receptor signalling inhibitor and the submission follows positive results from the pivotal phase III AFFIRM study, which confirmed that enzalutamide demonstrated a statistically significant improvement (p<0.0001) in overall survival with a median improvement over placebo of 4.8 months [hazard ratio (HR) = 0.631]. The study also concluded that enzalutamide was generally well tolerated by patients and met all secondary endpoints.
Enzalutamide licensed from Medivation
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