FDA Grants Priority Review Status for Extended Xtandi Indication

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.