FDA accepts new drug application from androgen receptor (AR) antagonist darolutamide

today, Bayer(http://and Orion announced that the U.SFDA(http://accepted the company's application fornew drug(http://(NDA) for the androgen receptor (AR) antagonist darolutamide for the treatment of non-metastatic resistance prostate cancer (CRNM)At the same time, the FDA grants the application a priority review qualificationAbout Darolutamide
Darolutamide is a nonsteroidal androgen receptor antagonistIt has a unique chemical structure that binds to AR with high affinity and exhibits strong antagonismTherefore, it can inhibit the proliferation of AR function and prostate cancer cellsin preclinical studies, darolutamide was less able to cross the blood-brain barrier than existing AR antagonists, reducing its possible side effectsThe granting of priority review qualifications is based on darolutamide's performance in the phase 3 ClinicalTrial(http://called ARAMISIn this randomized double-blind, placebo-controlled Phase 3 clinical trial, 1,509 nmCRPC patients received darolutamide or placebo treatmentresults showed that the median non-metastatic survival in patients in the darolutamide treatment group was 40.4 months, compared with 18.4 months in the control groupDarolutamide reduced the risk of cancer metastasis or death by 59% (HR s.0.41, p 0.001).