Bayer to seek FDA approval for another prostate cancer indication for darolutamide (Nubeqa) following positive phase III survival data
In phase III ARASENS study (n=1306), darolutamide, an androgen-receptor inhibitor, combined with androgen deprivation therapy and docetaxel improved survival & reduced risk of death for patients with metastatic hormone-sensitive prostate cancer (4 year survival rate 62.7 v 50.4%)
Source:
Biospace Inc.
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SPS commentary:
In UK, darolutamide is currently licensed for the treatment of adult men with non-metastatic castration resistant prostate cancer (who are at high risk of developing metastatic disease).