Shots:
- The US FDA has approved Nubeqa (darolutamide) in combination with androgen deprivation therapy (ADT) ± docetaxel to treat mHSPC pts; approval process in the EU is ongoing
- Approval was based on the P-III (ARANOTE) trial evaluating Nubeqa (600mg, BID) + ADT (n=446) vs PBO + ADT (n=223) in 669 mHSPC pts
- Trial showed a 46% reduction in rPFS (1EP), with consistent benefit observed across all subgroups, incl. a 40% & 70% risk reduction in pts with high-volume & low-volume disease, respectively; data was presented at ESMO 2024 & published in The JCO
Ref: Bayer | Image: Bayer| Press Release
PharmaShots! Your go-to media platform for customized news ranging for multiple indications. For more information connect with us at connect@pharmashots.com
