Nubeqa approved by MHLW in Japan for additional indication of metastatic prostate cancer
The Ministry of Health, Labor and Welfare (MHLW) in Japan has approved the oral androgen receptor inhibitor (ARi) darolutamide plus ADT in combination with docetaxel in the indication of metastatic prostate cancer
The MHLW approval is based on the positive results from the Phase III ARASENS trial, which demonstrated that darolutamide plus androgen deprivation therapy (ADT) in combination with docetaxel significantly reduced the risk of death by 32.5% compared to ADT with docetaxel, in patients with metastatic hormone-sensitive prostate cancer (mHSPC). Additionally, the darolutamide combination showed consistent benefits across clinically relevant secondary endpoints, with the overall incidence of treatment-emergent adverse events being similar between treatment arms.
These results were published in The New England Journal of Medicine (previously cited).Darolutamide is already approved in Japan for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC) under the brand name Nubeqa.
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