- (PLX AI) – Bayer submits application in China for additional indication of darolutamide.
- • Submission to the Center of Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) for an additional indication in patients with metastatic hormone-sensitive prostate cancer (mHSPC)
- • Submission based on data from the pivotal Phase III ARASENS trial, showing that the use of darolutamide plus androgen deprivation therapy (ADT) and docetaxel led to a statistically significant improvement in overall survival (OS) compared to ADT plus docetaxel, as well as consistent benefits in key secondary endpoints in patients with mHSPC, with similar overall rates of adverse events (AEs) between study arms
- • Darolutamide is approved under the brand name Nubeqa in non-metastatic castration-resistant prostate cancer (nmCRPC), in more than 60 markets around the world; additional submissions in mHSPC are planned globally
- • Broad development program underway with additional ongoing or planned large clinical studies for darolutamide across various stages of prostate cancer