Bayer’s Nubeqa (darolutamide) Receives MHLW’s Approval for Men with Non-Metastatic Castration-Resistant Prostate Cancer

Shots:

• The approval is based on P-III ARAMIS study assessing Nubeqa (600mg, qd) + ADT vs PBO + ADT in 1,509 patients in a ratio (2:1) with nmCRPC
• The P-III ARAMIS study results: improvement in 1EPs of MFS (40.4mos. vs 18.4mos.); MFS is supported by delay in time to pain progression and other 2EPs i.e, time to cytotoxic CT, time to SSE
• Nubeqa is an Ari, co-developed by Bayer and Orion Corporation, being evaluated in P-III ARASENS study for m-hormone-sensitive PC and an approved therapy in the US and Brazil and is underway in EU and other regions

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