Posted by Michael Wonder on 24 Oct 2016
FDA approves supplemental new drug application for Xtandi in advanced prostate cancer
24 October 2016 - Astellas and Pfizer today announced the U.S. FDA approved a supplemental new drug application to update the U.S. product labeling for Xtandi (enzalutamide) capsules to include new clinical data versus bicalutamide from the TERRAIN study.
The data demonstrate improvement in radiographic progression-free survival (rPFS) in patients with metastatic castration-resistant prostate cancer who were treated with enzalutamide compared to patients who were treated with bicalutamide.
