Medivation and Astellas Pharma have announced the submission of new drug application (NDA) for enzalutamide (formerly MDV3100) to the FDA.
The enzalutamide has been studied in patients with castration-resistant prostate cancer who have received docetaxel therapy.
The oral once-daily investigational agent is an androgen receptor signalling inhibitor.
Enzalutamide inhibits testosterone binding to androgen receptors, nuclear translocation of androgen receptors and DNA binding and activation by androgen receptors.
Medivation has applied for priority review, a designation given to drugs that offer a significant improvement in treatment or provide treatment where no satisfactory alternative therapy exists.
The FDA target for completing a review in six months, if priority review is granted.
