Posted by Michael Wonder on 15 Oct 2024
Bayer submits application for third indication of darolutamide in the EU
14 October 2024 - Submission is based on positive results from the pivotal Phase 3 ARANOTE trial, which showed that darolutamide plus androgen deprivation therapy significantly reduced the risk of radiological progression or death by 46% compared to placebo plus androgen deprivation therapy in patients with metastatic hormone sensitive prostate cancer.
Bayer today announced the submission of an application to the EMA for the oral androgen receptor inhibitor darolutamide.
