Home » FDA Grants Priority Review Status for Extended Xtandi Indication
FDA Grants Priority Review Status for Extended Xtandi Indication
Drugs Submissions and Approvals
The FDA granted priority review status to Pfizer and Astellas’ supplemental NDA for a non-metastatic castration-resistant prostate cancer indication for their drug Xtandi.
The FDA approved Xtandi, an inhibitor of androgen receptor, in 2012 for metastatic castration-resistant prostate cancer previously treated with docetaxel. The agency expanded it to all patients with metastatic CRPC in 2014.
The agency based its decision on the results of a 1,401-patient Phase III trial that found significant decreases in risk of metastasis.