Bayer and Orion announced that the FDA approved Nubeqa (darolutamide) for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC). The companies noted that clearance of the non-steroidal androgen receptor inhibitor came three months ahead of the regulator's target action date after the application was granted priority review in April.
According to Bayer and Orion, approval of Nubeqa is based on data from the Phase III ARAMIS trial, which met its primary endpoint of metastasis-free survival (MFS) last year. Results later presented at the Genitourinary Cancers Symposium (ASCO GU) showed that median MFS was 40.4 months for Nubeqa plus androgen deprivation therapy (ADT), versus 18.4 months for placebo plus ADT. In addition, a positive trend in overall survival was also seen, with an interim analysis demonstrating a 29% reduction in the risk of death for Nubeqa.
"The overarching goals of treatment in this setting are to delay the spread of prostate cancer and limit the burdensome side effects of therapy," remarked Christer Nordstedt, senior vice president of R&D at Orion, adding Nubeqa "provides nmCRPC patients a new therapeutic option that addresses these questions." Bayer has filed for approval of the drug in the EU, Japan and other countries.
Nubeqa, which is being jointly developed by Bayer and Orion under a 2014 partnership, is also being investigated in the Phase III ARASENS study in metastatic hormone-sensitive prostate cancer.
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