Orion and Bayer have completed a rolling submission of a New Drug Application (NDA) for darolutamide to the US Food and Drug Administration (FDA).
The decision is based on data from the Phase III ARAMIS trial in men with non-metastatic castration-resistant prostate cancer (nmCRPC), which showed a statistically significant improvement in metastasis-free survival (MFS) for darolutamide when used with androgen deprivation therapy (ADT).
The ARAMIS trial consisted of 1,509 patients and found that darolutamide in combination with ADT showed a favourable safety profile compared to placebo plus ADT.
Bayer has been granted Fast Track designation by the FDA for the drug in men with nmCRPC, and is also in discussions with other health authorities regarding a submission. The compound is being developed jointly by Orion and Bayer.
"Darolutamide is highly effective in the patient population with non-metastatic castration-resistant prostate cancer, and it has a side-effect profile that parallels that of placebo. Patients who received darolutamide had substantially longer MFS in the ARAMIS trial, and there was also a strong trend for improved overall survival.
"These results are truly exciting. We are looking forward to taking the next steps in bringing Darolutamide to men with nmCRPC and their treating physicians", said Christer Nordstedt, MD, PhD, senior vice president, Research and Development, Orion Corporation.
The data was also presented at the American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU) in San Francisco and published simultaneously in The New England Journal of Medicine.