Pfizer, Astellas' XTANDI Gets Priority Review In Non-metastatic Castration-sensitive Prostate Cancer

(RTTNews) - Pfizer Inc. (PFE) and Astellas Pharma Inc. Wednesday said the Food and Drug Administration (FDA) has granted priority review for the companies' supplemental New Drug Application (sNDA) for XTANDI for the treatment of patients with non-metastatic castration-sensitive prostate cancer (nmCSPC) with high-risk biochemical recurrence (BCR).

A decision from the regulator is expected in the fourth quarter.

XTANDI is currently approved in more than 100 countries to treat one or more of the indications including metastatic castration-sensitive prostate cancer, metastatic castration-resistant prostate cancer, and non-metastatic castration-resistant prostate cancer.