Bayer Reports the US FDA’s sBLA Acceptance of Nubeqa (Darolutamide) to Treat Metastatic Hormone-Sensitive Prostate Cancer
Shots:
- The US FDA has accepted for review the sBLA of Nubeqa plus androgen deprivation therapy (ADT) for treating metastatic hormone-sensitive prostate cancer (mHSPC)
- The sBLA was supported by P-III (ARANOTE) study assessing the safety & efficacy of Nubeqa (600mg, BID) in addition to ADT vs PBO for treating mHSPC patients (n=669), with the results highlighted at ESMO 2024 and published in The Journal of Clinical Oncology
- Results demonstrated significant reduction in the progression or death risk with the combination of Nubeqa & ADT without new safety concerns
Ref: Bayer Image: Bayer
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
