Posted by Michael Wonder on 16 Feb 2019
Phase III trial of darolutamide in patients with non-metastatic castration-resistant prostate cancer meets primary endpoint
24 October 2018 - Bayer has been granted fast track designation by the U.S. FDA for darolutamide in men with nmCRPC.
The Phase III ARAMIS (Androgen Receptor inhibiting Agent for MetastatIc-free Survival) trial that investigated darolutamide in men with non-metastatic castration-resistant prostate cancer (nmCRPC), met its primary endpoint. Darolutamide significantly extended metastasis-free survival compared to placebo. The safety profile and the tolerability of darolutamide observed in the ARAMIS trial were consistent with previously published data on darolutamide.
ARAMIS is a randomised, multi-center, double-blind, placebo-controlled trial in patients with nmCRPC.
