Marketing authorization granted for darolutamide in Japan
(WorldNews Finland)

1/23/2020 Marketing authorization granted for darolutamide in Japan ORION CORPORATION PRESS RELEASE 23 JANUARY 2020 at 8.30 EET The Japanese Ministry of Health, Labor and Welfare (MHLW) has granted marketing authorization for darolutamide, under the brand name Nubeqa®, 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), with a median 40.4 months for darolutamide plus ADT...