Bayer Reports Regulatory Submission of Nubeqa to the US FDA for Treating Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
Shots:
- Bayer has submitted the sNDA of Nubeqa (darolutamide), combined with androgen deprivation therapy (ADT), to the US FDA for treating mHSPC. Bayer & Orion Corporation together developed darolutamide
- Application was supported by the P-III (ARANOTE) study evaluating the safety & efficacy of Nubeqa (600mg, BID) + ADT vs PBO for treating mHSPC patients (n=669)
- Study demonstrated reduced the risk of radiological progression or death by 46% and consistent benefits in rPFS across subgroups (high & low-volume mHSPC). Safety and tolerability were similar to ARAMIS and ARASENS studies, with low TEAEs. Data was highlighted at ESMO 2024 & published in The Journal of Clinical Oncology
Ref: Bayer | Image: Bayer
Related News: Bayer's Nubeqa (darolutamide) Receives the EC's Approval for Men with Non-Metastatic Castration-Resistant Prostate Cancer
PharmaShots! Your go-to media platform for customized news ranging for multiple indications. For more information connect with us at connect@pharmashots.com
Click here to read the full press release
Tags
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.
