Bayer Reports the Regulatory Submission of Nubeqa (Darolutamide) to the EMA for Treating Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
Shots:
- Bayer has submitted regulatory application of Nubeqa plus ADT to the EMA for treating mHSPC, based on the results from P-III (ARANOTE) study; data was highlighted at ESMO 2024 & published in The Journal of Clinical Oncology. The combination is also approved for nmCRPC
- The P-III (ARANOTE) study evaluated the safety & efficacy of Nubeqa (600mg, BID) in combination with ADT vs PBO for treating patients (n=669) with mHSPC
- Study depicted a significant reduction in the radiological progression or death by 46% with similar rPFS benefits observed in the prespecified subgroups such as patients with high & low-volume mHSPC. TEAEs were low & consistent across the groups with a safety profile aligning with the ARAMIS & ARASENS studie
Ref: Bayer | Image: Bayer
Related News: Bayer Reports Regulatory Submission of Nubeqa to the US FDA for Treating Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
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
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.
