Bayer’s Nubeqa Receives Expanded Approval in India for mHSPC with ADT 

Key Highlights: 

• Bayer announced that its androgen receptor inhibitor Nubeqa has received regulatory approval for the treatment of patients with metastatic hormonesensitive prostate cancer when used in combination with docetaxel and androgen deprivation therapy (ADT). 

• The approval is supported by results from the ARASENS phase III study, which demonstrated that adding Nubeqa to ADT plus docetaxel significantly improved overall survival compared with ADT and docetaxel alone in patients with metastatic hormone-sensitive prostate cancer. 

• With this approval, Nubeqa further expands its role across prostate cancer treatment settings and strengthens Bayer’s oncology portfolio, offering physicians an additional treatment option aimed at improving survival outcomes in patients with advanced prostate cancer. 

Implications: 

Nubeqa’s India approval intensifies mHSPC competition against Janssen’s Erleada, amid prostate therapeutics market growing at 8.2% CAGR to $739M by 2030. 
With global Nubeqa sales hitting €1.5B in 2024 (up 75% YoY) and India incidence rising, Bayer eyes 15-20% local share via its sales/marketing infrastructure, pressuring docetaxel generics. 
In Saudi/India, this bolsters Bayer’s oncology pivot, fueling PE interest in urology combos as cases surge ~25% through 2030. 

Source: Express Pharma | Image: Bayer