Bayer has submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA) for darolutamide for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC).
Men are typically asymptomatic at this stage of prostate cancer. Therefore, it is critical that they have treatment options, which not only delay the development of metastases, but also limit burdensome side effects of therapy, so that these men can continue with their day-to-day lives. With this submission, we are taking an important step toward providing patients, caregivers, and physicians with a potential new treatment option for nmCRPC,
said Scott Z. Fields,
M.D., senior vice president
and head of Oncology Development
of Bayer AG’s Pharmaceutical Division.
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).