Orion wins approval for darolutamide in Japan for metastatic prostate cancer
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- Finnish pharmaceutical company Orion (OTCPK:ORINY) announced Monday that the government of Japan approved its oral androgen receptor inhibitor darolutamide for metastatic prostate cancer in combination with androgen deprivation therapy (ADT) and docetaxel.
- Darolutamide, which is developed by Orion (OTCPK:ORINY) in partnership with Bayer (OTCPK:BAYZF) (OTCPK:BAYRY), is already approved in Japan as Nubeqa for non-metastatic castration-resistant prostate cancer (nmCRPC).
- The new approval is based on data from the pivotal Phase 3 ARASENS trial, in which darolutamide plus ADT and chemotherapy docetaxel cut mortality risk by ~33% compared to ADT with docetaxel in metastatic hormone-sensitive prostate cancer (mHSPC).
- In late January, an expert panel in Europe backed marketing authorization for Nubeqa for mHSPC in combination with ADT and docetaxel.