Summary

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• Darolutamide (Nubeqa) is indicated for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC) and metastatic hormone-sensitive prostate cancer (mHSPC) in combination with docetaxel.
• The review encompassed 26 studies, all categorized as Systematic Reviews / Meta-Analyses.
• In nmCRPC, darolutamide shows significant improvements in metastasis-free survival compared to placebo and has a potential favorable option for overall survival with lower toxicity than enzalutamide and apalutamide.
• For safety in nmCRPC, darolutamide tends to have fewer severe adverse events such as cognitive impairments, hypertension, fatigue, and fractures compared to other androgen receptor inhibitors like enzalutamide and apalutamide.
• In mHSPC combined therapy settings involving docetaxel and androgen deprivation therapy (ADT), darolutamide significantly improves overall survival and progression-free survival over ADT alone or other combinations.
• Safety data suggest that adding darolutamide to triplet therapies does not substantially increase severe adverse event risks compared to using docetaxel plus ADT alone; it also shows better tolerance concerning cardiovascular events and cognitive impairments relative to enzalutamide or abiraterone.
• Combination therapies including darolutamide improve outcomes irrespective of patient subgroups defined by Gleason scores or presence of visceral metastasis indicating robust utility across diverse populations within mHSPC treatments.