EU approves Nubeqa for castration-resistant prostate cancer .- Orion + Bayer
The approval is based on Phase III ARAMIS trial results showing a statistically significant improvement in metastasis-free survival (MFS) for darolutamide plus androgen deprivation therapy (ADT) versus placebo plus ADT, and a favorable safety profile. Results demonstrated a highly significant improvement in the primary efficacy endpoint of metastasis-free survival (MFS) of darolutamide plus ADT, with a median of 40.4 months, versus 18.4 months for placebo plus ADT (p<0.001), and a favorable safety profile. the compound is indicated for the treatment of men with non-metastatic castration-resistant prostate cancer (nmcrpc), who are at high risk of developing metastatic disease.></0.001),>
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