Bayer completes US filing for prostate cancer drug darolutamide

Bayer has completed its rolling marketing application for prostate cancer drug darolutamide in the US, setting up possible approval later this year and a market clash with Pfizer/Astellas and Johnson & Johnson. The filing is based on data from the phase III ARAMIS trial of Orion-partnered darolutamide plus androgen deprivation therapy (ADT) in patients with non-metastatic castration-resistant prostate cancer (CRPC). The results were published in the New England Journal of Medicine earlier this month and showed the drug extended metastasis-free survival (MFS) compared to placebo plus ADT. Darolutamide is being cued up as a rival to J&J’s already-marketed androgen receptor antagonist Erleada (apalutamide) as well as Pfizer/Astellas’ Xtandi (enzalutamide), which are already approved for non-metastatic CRPC and so will be the primary, direct competitors for darolutamide if it reaches the market.