Singapore, Jan. 24 -- The Japanese Ministry of Health, Labor and Welfare (MHLW) has granted marketing authorization for darolutamide, under the brand name Nubeqa(R), for the treatment of men with non-metastatic castration-resistant prostate cancer (nmCRPC).

The approval is based on the Phase III ARAMIS trial evaluating the efficacy and safety of darolutamide plus androgen deprivation therapy (ADT) compared to placebo plus ADT, showing a highly significant improvement in the primary efficacy endpoint of metastasis-free survival (MFS).

The androgen receptor inhibitor (ARi), which is jointly developed by Orion and Bayer is already approved in the U.S. and Brazil and filings in the European Union and other regions are underway or planned by...