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

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

Shots:

  • The EC’s approval is based on P-III ARAMIS study assessing Nubeqa (600mg, bid) + ADT vs PBO + ADT 1,509 patients in a ratio (2:1) with nmCRPC
  • The P-III ARAMIS study results: improvement in 1EPs of MFS (40.4 vs 18.4mos.), showed a delay in time to pain progression. Time to cytotoxic CT and time to SSE also demonstrated a benefit in favor of Nubeqa at the time of final MFS analysis
  • Nubeqa is an ARi that binds to the receptor with high affinity, thus inhibiting the growth of prostate cancer cells and is an approved therapy in the US, Brazil, Australia, Canada, and Japan

Click here ­to­ read full press release/ article | Ref: Bayer | Image: Lucky step