www.fdanews.com/articles/196459-bayers-nubeqa-grabs-ec-approval-for-prostate-cancer
Bayer’s Nubeqa Grabs EC Approval for Prostate Cancer
March 31, 2020
The European Commission has approved Bayer’s Nubeqa (darolutamide) for treatment of men with non-metastatic castration-resistant prostate cancer who are at high risk of developing metastatic disease.
The approval was based on the results of a phase 3 clinical trial, in which Nubeqa demonstrated a significant improvement in metastasis-free survival and a favorable safety profile.
Nubeqa is currently approved in five other countries including the U.S., and regulatory filings in other countries are underway or planned.