Xtandi: oral anti-androgen for metastatic prostate cancer

PHARMACOLOGY

Enzalutamide is a potent androgen-receptor signalling inhibitor. It competitively inhibits binding of androgens to androgen receptors, nuclear translocation of activated receptors and the association of activated androgen receptors with DNA.¹

CLINICAL STUDIES

In the phase III AFFIRM study, 1199 men with metastatic castration-resistant prostate cancer previously treated with docetaxel and who were currently using a gonadotrophin-releasing hormone analogue or had undergone orchidectomy were randomised to receive enzalutamide 160mg once daily (n=800) or placebo (n=399).²

Overall survival, the primary endpoint, was significantly higher with enzalutamide than with placebo in the intent-to-treat analysis: 308 deaths (38.5%) occurred in the enzalutamide group compared with 212 deaths (53.1%) in the placebo group (p<0.0001).²

References:

1. Xtandi Summary of Product Characteristics, June 2013.
2. Scher HI et al. N Engl J Med 2012; 367: 1187–97.

View Xtandi drug record

Further information: Astellas Pharma

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