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Pharmaceuticals / Submissions and Approvals

Orion and Bayer’s Prostate Cancer Drug Nubeqa Approved by FDA

Aug. 5, 2019

The FDA has approved Orion and Bayer’s Nubeqa (darolutamide) for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC).

The agency based its decision on the results of a Phase 3 trial, which showed Nubeqa plus androgen deprivation therapy (ADT) demonstrating “highly significant improvement” in metastasis-free survival (MFS). The drug alongside ADT provided a median of 40.4 months of MFS compared to placebo and ADT’s 18.4 months.

“The overarching goals of treatment in this setting are to delay the spread of prostate cancer and limit the burdensome side effects of therapy,” said Christer Nordstedt, senior vice president of Orion R&D. “Darolutamide provides nmCRPC patients a new therapeutic option that addresses these questions.”

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