www.fdanews.com/articles/195292-pfizers-xtandi-approved-for-metastatic-castration-sensitive-prostate-cancer
Pfizer’s Xtandi Approved for Metastatic Castration-Sensitive Prostate Cancer
December 27, 2019
The FDA approved Pfizer’s Xtandi (enzalutamide) for treating patients with metastatic castration-sensitive prostate cancer.
The approval makes Xtandi the first and only oral treatment approved by the FDA for three distinct forms of advanced prostate cancer. The drug has also been approved for non-metastatic and metastatic castration-resistant prostate cancer.
The agency based the approval on results of a randomized phase 3 study that evaluated 150 men with mCSPC and achieved the primary endpoint of radiographic progression-free survival.