Bayer’s Nubeqa (darolutamide) Receives the US FDA’s Approval for Non-Metastatic Castration-Resistant Prostate Cancer in Men

Bayer’s Nubeqa (darolutamide) Receives the US FDA’s Approval for Non-Metastatic Castration-Resistant Prostate Cancer in Men

Shots:

  • The approval is based on P-III ARAMIS study results assessing Nubeqa (600mg, bid) + ADT vs PBO + ADT in 1,509 in patients in a ratio (2:1) with nmCRPC. Nubeqa is approved under FDA’s PR designation and a three mos. ahead of its PDUFA date
  •  The P-III ARAMIS study resulted in meeting its 1EPs i.e, MFS (40.4 vs 18.4mos.), delay in time to pain progression, time to cytotoxic chemotherapy, time to a symptomatic skeletal event demonstrated a benefit in favor of Nubeqa
  • Nubeqa is an androgen receptor inhibitor (ARi) binding it with high affinity thus inhibiting the growth of prostate cancer cells. Bayer has filed for its approval in the multiple countries including the EU and Japan

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