Posted by Michael Wonder on 22 Dec 2017
U.S. FDA grants priority review to Janssen for apalutamide as a treatment for non-metastatic castration-resistant prostate cancer
21 December 2017 - Apalutamide is the first agent submitted for approval to treat earlier stage castration-resistant prostate cancer at high risk for metastasis.
Janssen today announced that the U.S. FDA has granted priority review designation for the new drug application for apalutamide, an investigational, next-generation oral androgen receptor inhibitor for the treatment of men with non-metastatic castration-resistant prostate cancer (CRPC). Currently, there are no FDA-approved treatments for patients with non-metastatic CRPC.
The FDA has assigned a Prescription Drug User Fee Act target date of April 2018 to render a decision on the apalutamide application.
