Posted by Michael Wonder on 31 Jul 2019
U.S. FDA approves darolutamide, a new treatment for men with non-metastatic castration-resistant prostate cancer
31 July 2019 - Darolutamide was approved in the U.S. under the FDA priority review designation; approval granted three months ahead of target FDA action date.
The U.S. FDA has approved darolutamide, a non-steroidal androgen receptor inhibitor, under the brand name Nubeqa.
The FDA approval is for the treatment of patients with non-metastatic castration-resistant prostate cancer and is based on the Phase III ARAMIS trial evaluating darolutamide plus androgen deprivation therapy, which demonstrated a highly significant improvement in the primary efficacy endpoint of metastasis-free survival, with a median of 40.4 months versus 18.4 months for placebo plus ADT (p<0.0001).
