Xtandi: oral anti-androgen for metastatic prostate cancer

Xtandi (enzalutamide) is an anti-androgen licensed for the treatment of metastatic castration-resistant prostate cancer following the failure of docetaxel-based chemotherapy.

Xtandi (enzalutamide) has been shown to inhibit the effects of androgens even in the setting of androgen receptor overexpression and in prostate cancer cells resistant to anti-androgens.
Xtandi (enzalutamide) has been shown to inhibit the effects of androgens even in the setting of androgen receptor overexpression and in prostate cancer cells resistant to anti-androgens.

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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