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Bayer Reports EC’s Approval of Nubeqa for Treating Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)

Shots:

  • The EC has approved Nubeqa (darolutamide) in combination with androgen deprivation therapy (ADT) ± docetaxel to treat mHSPC pts
  • Approval was based on the P-III (ARANOTE) trial evaluating Nubeqa (600mg, BID) + ADT vs PBO + ADT in 669 mHSPC pts
  • Trial showed a 46% reduction in rPFS (1EP), with consistent benefit observed across all subgroups, incl. pts with high-volume & low-volume disease; data was presented at ESMO 2024 & published in The JCO

Ref: Bayer | Image: Bayer | Press Release

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