Recently, it was announced that there was a submission by Astellas and Medivation to the European Regulatory Agency for Enzalutamide (MDV-3100) for the treatment of men with advanced prostate cancer post-chemotherapy
The basis of the submission was the pivotal phase 3 AFFIRM study.
The Marketing Authorization Application (MAA) that was made to the European Medicines Agency (EMA) for Enzalutamide was for the treatment of men with metastatic castration-resistant prostate cancer who have been previously treated with docetaxel-based chemotherapy.
Enzalutamide is an oral, once-daily, investigational agent that works as an androgen receptor signaling inhibitor, sometimes it is referred to as “super Casodex.” In addition to the European application there has been A New Drug Application (NDA) submitted in the United States, where a priority review.
Enzalutamide inhibits androgen receptor signaling in three ways: it inhibits 1) testosterone binding to androgen receptors; 2) nuclear trans-location of androgen receptors; and 3) DNA binding and activation by androgen receptors.
The AFFIRM trial was halted early after yielding positive results from an interim analysis. According to the data monitoring committee for the study, at the time the trial was stopped, Enzalutamide produced a 4.8-month advantage in median overall survival compared to placebo.
Currently, in the United States there is an early access trial available to get the drug now. For additional information about this trial and how to access it search “MDV-3100 early access” on this blog.
News about the Global Prostate Cancer Alliance can be found at http://prostatecanceralliance.org
Joel T Nowak, M.A., M.S.W.