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Bayer and Orion's Nubeqa secures FDA approval in non-metastatic castration-resistant prostate cancer

Published on 31/07/19 at 11:18am

The FDA has awarded approval under its Priority Review pathway to Nubeqa (darolutamide) for the treatment of non-metastatic castration-resistant prostate cancer (nmCRPC), it has emerged.

The decision to authorise the non-steroidal androgen receptor inhibitor (ARi), which is jointly developed by Orion and Bayer, was based on Phase 3 data which demonstrated that Nubeqa, in combination with androgen deprivation therapy (ADT), improved metastasis-free survival by a median of 40.4 months compared to 18.4 months with placebo plus ADT, meeting its primary endpoint.

Additionally, the findings of the trial showed a positive trend in overall survival, but full data was not considered mature at the time of final analysis.

“Patients with nmCRPC are usually asymptomatic, but have a rising blood PSA despite ADT treatment, and it is important to prevent their cancer from becoming metastatic and symptomatic,” commented Christer Nordstedt, Senior Vice President, Research and Development at Orion. “The overarching goals of treatment in this setting are to delay the spread of prostate cancer and limit the burdensome side effects of therapy. Darolutamide provides nmCRPC patients a new therapeutic option that addresses these questions”

It was noted that Bayer has also submitted the therapy for approval in the European Union, Japan and other health authorities.

Matt Fellows

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