FDA Approves Expanded Use For Bayer's Prostate Cancer Drug

  • The FDA approved Bayer AG's BAYRY supplemental marketing application for Nubeqa (darolutamide) with docetaxel for metastatic hormone-sensitive prostate cancer (mHSPC).
  • The approval is based on the results of Phase 3 ARASENS trial that demonstrated a reduction in the risk of death by 32% in Nubeqa plus androgen deprivation therapy and docetaxel compared to ADT and docetaxel.
  • Nubeqa plus ADT and docetaxel also resulted in a statistically significant delay in time to pain progression.
  • The recommended darolutamide dose for mHSPC is 600 mg (two 300 mg tablets) taken orally, twice daily, with food until unacceptable toxicity or disease progression. 
  • Docetaxel, 75 mg/m2 intravenously, is administered every three weeks for up to 6 cycles. The first dose of docetaxel should be administered within six weeks after starting darolutamide treatment.
  • In 2019, the FDA approved Nubeqa for non-metastatic castration-resistant prostate cancer (nmCRPC), receiving a concomitant gonadotropin-releasing hormone analog or analog had a bilateral orchiectomy.
  • Price Action: BAYRY shares closed lower by 7.09% at $13.63 on Friday.
Posted In: BiotechNewsHealth CareFDAGeneralBriefs