Bayer submits application in China for additional indication ...
Bayer submitted a regulatory application to China’s NMPA for darolutamide, an oral androgen receptor inhibitor, to treat metastatic hormone-sensitive prostate cancer (mHSPC) with docetaxel. Supported by Phase III ARASENS trial results showing improved overall survival, darolutamide, marketed as Nubeqa™, is already approved in over 60 markets for non-metastatic castration-resistant prostate cancer. Bayer aims to address the rising prostate cancer incidence in China, emphasizing the need for treatments that extend survival and delay disease progression.
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Bayer submitted a regulatory application to China’s NMPA for darolutamide, an oral androgen receptor inhibitor, to treat metastatic hormone-sensitive prostate cancer (mHSPC) with docetaxel. Supported by Phase III ARASENS trial results showing improved overall survival, darolutamide, marketed as Nubeqa™, is already approved in over 60 markets for non-metastatic castration-resistant prostate cancer. Bayer aims to address the rising prostate cancer incidence in China, emphasizing the need for treatments that extend survival and delay disease progression.
Bayer submitted an application to Japan's MHLW for darolutamide's new indication, combining it with docetaxel and ADT for metastatic prostate cancer treatment. This follows positive Phase III ARASENS trial results showing improved survival. Darolutamide, marketed as Nubeqa™, is already approved for non-metastatic castration-resistant prostate cancer in over 60 markets.