European regulator clears Bayer, Orion's Nubeqa for non-metastatic castration-resistant prostate cancer

Bayer announced that the European Commission approved Nubeqa (darolutamide) for the treatment of men with non-metastatic castration-resistant prostate cancer (nmCRPC), who are at high risk of developing metastatic disease. The oral androgen receptor inhibitor, also known as ODM-201, is being jointly developed by Bayer and Orion.

The companies noted that approval is based on data from the Phase III ARAMIS trial, with results showing a significant improvement in metastasis-free survival (MFS) for Nubeqa plus androgen deprivation therapy (ADT), with a median of 40.4 months, versus 18.4 months for placebo plus ADT. Earlier this year, Bayer and Orion said that results from the study also showed that Nubeqa significantly improved overall survival (OS) compared to placebo.

The companies previously indicated that "a positive trend" in OS had also been seen, with an interim analysis demonstrating a 29% reduction in the risk of death for Nubeqa. Following the latest data, Robert LaCaze, head of Bayer's oncology strategic business unit, remarked "we expect to report results from the pre-planned OS analysis at an oncology meeting later this year."

Nubeqa has also received clearance in the US, Australia, Brazil, Canada as well as Japan, and filings in other regions are under way.

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