Updated on 3 September 2012
"We believe Xtandi has the potential to play an important role in the treatment of advanced prostate cancer," said Dr Stephen Eck, vice president of medical oncology, Astellas Pharma Global Development. "We're eager to work with Medivation to make this much-needed new treatment available to medical professionals and patients in September."
As a post-marketing requirement, Medivation and Astellas have agreed with the FDA to conduct an open-label safety study of Xtandi (160 mg/day) in patients who are at high risk for seizure.
Medivation and Astellas have agreed to provide the data from this study in 2019.