Darolutamide submitted for EU approval

The groups are seeking permission to market the drug to treat patients with non-metastatic castration-resistant prostate cancer, on the back of positive data from the Phase III ARAMIS study.

The study results showed a statistically significant improvement in metastasis-free survival (MFS) for darolutamide in combination with androgen deprivation therapy (ADT), with results 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.

Darolutamide is a non-steroidal androgen receptor (AR) antagonist with a distinct chemical structure that binds to the receptor with high affinity and exhibits strong antagonistic activity, inhibiting the receptor function and the growth of prostate cancer cells.

It is not yet approved by the US Food and Drug Administration (FDA), the European Medicines Agency or any other health authority.

"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," said Christer Nordstedt, senior vice president, research and development, Orion. "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"

Prostate cancer is the second most commonly diagnosed malignancy in men worldwide, with an estimated 1.2 million men diagnosed with prostate cancer in 2018, and about 358,000 deaths from the disease worldwide.