The US Food and Drug Administration (FDA) has accepted a new drug application for review and granted priority review for darolutamide.
The decision is good news for patients with non-metastatic castration-resistant prostate cancer (nmCRPC), and was based on data from the Phase III ARAMIS trial in men with nmCRPC.
In addition to the trial, darolutamide is also being investigated in a Phase III study in metastatic hormone-sensitive prostate cancer (ARASENS).
Bayer recently submitted an application to the European Medicines Agency and the Ministry of Health, Labor and Welfare (MHLW) in Japan, and is also in discussions with other health authorities regarding submissions.
"Darolutamide is highly effective in the patient population with non-metastatic castration-resistant prostate cancer, and it has few adverse effects with a profile that parallels that of placebo. We are looking forward to taking the next steps in bringing darolutamide to men with nmCRPC and their treating physicians," said Christer Nordstedt, enior vice president, research and development, at Orion.
"With the NDA acceptance for review and Priority Review designation, we are an important step closer to bringing darolutamide to patients as quickly as possible".
Darolutamide is an investigational, non-steroidal androgen receptor antagonist with a distinct chemical structure that binds with high affinity to the receptor, inhibiting the growth of prostate cancer cells.