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Orion Corporation announced it has received approval from the US Food and Drug Administration for darolutamide, a new treatment for men with non-metastatic castration-resistant prostate cancer (nmCRPC).
In a July 31, 2019 press release, Finnish company, Orion Corporation, announced it has received approval from the US Food and Drug Administration for darolutamide, a new treatment for men with non-metastatic castration-resistant prostate cancer (nmCRPC).
Darolutamide is a non-steroidal androgen receptor inhibitor (ARi), which has been jointly developed by Orion Corporation and Bayer and will be marketed under the brand name Nubeqa. Approval from FDA was granted based on the results of the Phase III ARAMIS trial, which demonstrated a significant improvement in metastasis-free survival (primary endpoint) with darolutamide plus androgen deprivation therapy (ADT) in patients with nmCRPC.
“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,” said Christer Nordstedt, senior vice-president, Research and Development, Orion Corporation in the press release. “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.”
The approval was granted under FDA’s priority review process. Bayer has also filed for approval of the compound in the European Union, Japan, and with other health authorities.
Source: Orion Corporation