Medivation and Astellas Pharma have announced FDA approval for Xtandi (enzalutamide) capsules to treat metastatic castration-resistant prostate cancer in patients with previously received docetaxel.
Medivation and Astellas expect to make Xtandi, an androgen receptor inhibitor, available in the US in mid-September 2012. The European Medicines Agency has even accepted a marketing authorization application for Xtandi.
Medivation co-founder, president and CEO David Hung said, "We are proud to be in a position to offer a new treatment, Xtandi, for this patient population for which there is a significant unmet medical need."
The 160mg (four 40mg capsules) to be administered orally once daily is the dose recommended for Xtandi.
Medivation and Astellas have agreed with the FDA to conduct a Xtandi (160mg/day) open-label safety study in patients who are at high risk for seizure and provide the data in 2019, as a post-marketing requirement.