Bayer files for expansion of Nubeqa indication in US and EU

CompilationFan Dongdong

The latest news shows that Bayer has submitted approval applications to drug regulators in the United States and the European Union seeking approval for Nubeqa (darolutamide) in combination with the chemotherapy docetaxel for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC)

The filing is based on data from the ARASENS Phase 3 trial showing a statistically significant improvement in overall survival with Nubeqa combined with androgen deprivation therapy (ADT) and chemotherapy docetaxel in men with metastatic hormone-sensitive prostate cancer

Notably, the ARASENS trial (NCT02799602) is the only randomized, multi-label trial to test the efficacy of the second-generation androgen receptor inhibitor Nubeqa in combination with androgen deprivation therapy and docetaxel in patients with metastatic hormone-sensitive prostate cancer.

The results showed that Nubeqa, androgen deprivation therapy combined with docetaxel significantly reduced the risk of death by 32.

The currently approved indication of Nubeqa is non-metastatic castration-resistant prostate cancer (nmCRPC).

Prostate cancer is the second most common malignant tumor in men worldwide

However, about 5% of prostate cancer patients have already developed distant metastases when they are first diagnosed

Nubeqa was jointly developed by Bayer and the Finnish pharmaceutical company Orion Corporation

Reference source: Bayer Submits Applications in the US and EU for Additional Indication of NUBEQA® (darolutamide)