Bayer submits darolutamide for marketing authorization in Japan

Bayer has submitted an application for marketing authorization to the Ministry of Health, Labor and Welfare (MHLW) in Japan for darolutamide for the treatment of patients with castration-resistant prostate cancer (CRPC).

“In the early stage of prostate cancer, patients are typically asymptomatic. Thus, it is critically important for men to have treatment options that significantly delay the development of metastases while limiting burdensome side effects of therapy, which allow them to continue their day-to-day lives,” said Scott Z. Fields, M.D., senior vice president and head of Oncology Development at Bayer’s Pharmaceutical Division. “With this submission, we are one step closer to providing patients and physicians in Japan with a potential new treatment option for CRPC.”

The submission to the MHLW is based on data from the Phase III ARAMIS trial in men with nmCRPC. Data from ARAMIS showed a statistically significant improvement in metastasis-free survival (MFS) for darolutamide plus androgen deprivation therapy (ADT). These data 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.

Bayer recently completed the rolling submission of a New Drug Application to the United States Food and Drug Administration (FDA) and is also in discussions with other health authorities regarding submissions.

The compound is being developed jointly by Bayer and Orion Corporation, a globally operating Finnish pharmaceutical company.