Bayer Nubeqa (darolutamide) has been formally approved by the U.S. FDA for the treatment of nmCRPC

Today, Bayer announced that its Nubeqa (darolutamide) has been officially approved by the u.SFDA(http://for the treatment of non-metastatic resistant prostate cancer (nmCRPC)Nubeqa, an androgen receptor inhibitor (ARi), was approved by the FDA on April 30 this yearThe approval is based on the results of a three-stage ARAMIStrial(http://, a randomized double-blind placebo-controlled study of 1,509 patients who were receiving ADT as standard care therapy but had a high risk of metastatic diseaseIn the study, patients were randomly divided into two groups with a 2:1 ratio and were treated with Nubeqa combined ADT or placebo combined ADTThe results showed that the median non-metastatic survival (MFS) of Nubeqa combination therapy was 40.4 months, and the placebo combined ADT group reached the primary therapeutic end of 18.4 monthsAll other secondary endpoints are shown to favour NubeqaNubeqa combination therapy reduced the risk of disease transfer or death by 59% and reduced the risk of death by 29%In addition, the therapy was able to significantly extend progressionless life (median PFS: 36.8 months VS.14.8 months), reducing the risk of local progress or distant transfer or death by 62%