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Orion submitts Darolutamide for European marketing authorization


Orion Corporation and Bayer have announced that a marketing authorization application (MAA) has been  submitted to the European Medicines Agency (EMA) for darolutamide for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC).

Regulatory submission is based on positive data from Phase III study .

ARAMIS trial

The submission to the EMA is based on data from the Phase III ARAMIS trial in men with nmCRPC, which were recently 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, showing a statistically significant improvement in metastasis-free survival (MFS) for darolutamide plus androgen deprivation therapy (ADT).

Bayer recently completed the rolling submission of a New Drug Application to the United States Food and Drug Administration (FDA) and submitted an application to the Ministry of Health, Labor and Welfare (MHLW) in Japan. Bayer is also in discussions with other health authorities regarding submissions.

The next steps

The compound is being developed jointly by Orion Corporation 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, Senior Vice President, Research and Development, Orion Corporation.