German pharmaceutical and life sciences company Bayer AG (ETR:BAYN) (OTC:BAYRY) announced on Thursday that it is expanding the clinical development program for NUBEQA (darolutamide) in prostate cancer.
NUBEQA is an androgen receptor inhibitor (ARi) that competitively inhibits androgen binding, AR nuclear translocation and AR-mediated transcription.
A new Phase III clinical study will investigate the efficacy of NUBEQA plus androgen deprivation therapy (ADT) versus ADT alone in hormone-sensitive prostate cancer, in patients with high-risk biochemical recurrence (BCR) who have no evidence of metastatic disease by conventional imaging and a positive PSMA PET/CT at baseline. BCR is defined as rising prostate-specific antigen (PSA) levels with a doubling time of
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