FDA Approved Drugs » 2012
Medical Areas: Gastroenterology | Oncology | Family Medicine | Urology
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The following drug information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Approval Status: Approved August 2012
Treatment Area: metastatic castration-resistant prostate cancer
Xtandi (enzalutamide) is an androgen receptor inhibitor.
Xtandi is specifically indicated for the treatment of patients with metastatic castration-resistant prostate cancer who have previously received docetaxel.
Xtandi is supplied as a capsule for oral administration. The recommended dose of Xtandi is 160 mg (four 40 mg capsules) administered orally once daily. Xtandi can be taken with or without food. The capsules should be swallowed whole.
FDA ApprovalThe FDA approval of Xtandi was based on a randomized, placebo-controlled, multicenter trial in 1,199 subjects. The subjects were randomized to receive either Xtandi orally at a dose of 160 mg once daily (n=800) or placebo orally once daily (n=399). All subjects continued androgen deprivation therapy. The primary endpoint was overall survival. The pre-specified interim analysis at the time of 520 events showed a statistically significant improvement in overall survival in subjects on the Xtandi arm compared to those on the placebo arm. The number of deaths was 308 (38.5%) in the Xtandi arm versus 212 (53.1%) in the placebo arm. The median survival was 18.4 months in the Xtandi arm versus 13.6 months in the placebo arm (p< 0.0001).
Adverse events associated with the use of Xtandi may include, but are not limited to, the following:
Xtandi (enzalutamide) is an androgen receptor inhibitor that acts on different steps in the androgen receptor signaling pathway. Enzalutamide has been shown to competitively inhibit androgen binding to androgen receptors and inhibit androgen receptor nuclear translocation and interaction with DNA.
Scher HI, Fizazi K, Saad F, Taplin ME, Sternberg CN, Miller MD, de Wit R, Mulders P, Chi KN, Shore ND, Armstrong AJ, Flaig TW, Fléchon A, Mainwaring P, Fleming M, Hainsworth JD, Hirmand M, Selby B, Seely L, de Bono JS; the AFFIRM Investigators Increased Survival with Enzalutamide in Prostate Cancer after Chemotherapy. New England Journal of Medicine 2012 Aug 15
For additional information regarding Xtandi or prostate cancer, please visit the Medivation web page.