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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.

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