Bayer plans filings for prostate cancer drug darolutamide

Bayer is planning regulatory filings of darolutamide in prostate cancer following phase III trial results showing it helped prevent the disease from spreading, in a niche where Pfizer and Johnson & Johnson have already gained a foothold. The German pharma developed darolutamide in partnership with Finland’s Orion Corporation, with the latter due to a series of payments when the drug is filed in major markets.
The ARAMIS trial tested darolutamide in men with non-metastatic castration resistant prostate cancer (nmCRPC), to see if the drug could stop the disease from metastasising. Pfizer’s Xtandi (enzalutamide) has been approved as a way of preventing the disease from spreading after the FDA expanded its label earlier this year, and J&J’s newer drug Erleada (apalutamide) was also approved in this indication earlier this year.