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Home » Bayer’s 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.
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