Darolutamide

(Nubeqa)

Darolutamide

Drug updated on 11/14/2023

Dosage FormTablet (oral; 300 mg)
Drug ClassAndrogen receptor inhibitors
Ongoing and Completed StudiesClinicalTrials.gov

Indication

  • For the treatment of patients with non-metastatic castration-resistant prostate cancer.

Product Monograph / Prescribing Information

Document TitleYearSource
Nubeqa (darolutamide) Prescribing Information.2022Bayer HealthCare Pharmaceuticals Inc., Whippany, NJ

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Clinical and pharmacoeconomic combined report.2023CADTH
Darolutamide with androgen deprivation therapy and docetaxel for treating hormone-sensitive metastatic prostate cancer.2023NICE
Based on ARASENS trial: efficacy and safety of darolutamide as an emerging option of endocrinotherapy for metastatic hormone-sensitive prostate cancer—an updated systematic review and network meta-analysis.2023Journal of Cancer Research and Clinical Oncology
Comparison of treatments for nonmetastatic castration-resistant prostate cancer: matching-adjusted indirect comparison and network meta-analysis. 2022Journal of the National Cancer Institute
Efficacy and safety of therapies for advanced prostate cancer in Asia: evidence from a systematic literature review.2022Therapeutic Advances in Medical Oncology
Androgen receptor signaling inhibitors in addition to docetaxel with androgen deprivation therapy for metastatic hormone-sensitive prostate cancer: a systematic review and meta-analysis.2022European Urology
Overall survival and adverse events after treatment with darolutamide vs. apalutamide vs. enzalutamide for high-risk non-metastatic castration-resistant prostate cancer: a systematic review and network meta-analysis. 2021Prostate Cancer and Prostatic Diseases
Novel androgen receptor inhibitors in non-metastatic, castration-resistant prostate cancer: a systematic review and network meta-analysis. 2021Frontiers in Oncology
Systemic management for nonmetastatic castration-resistant prostate cancer: a systematic review and network meta-analysis. 2020American Journal of Clinical Oncology
A systematic review and network meta-analysis of novel androgen receptor inhibitors in non-metastatic castration-resistant prostate cancer. 2020Clinical Genitourinary Cancer
Role of novel hormonal therapies in the management of non-metastatic castration-resistant prostate cancer: a literature-based meta-analysis of randomized trials. 2020Clinical and Translational Oncology
Apalutamide, enzalutamide, and darolutamide for non‑metastatic castration‑resistant prostate cancer: a systematic review and network meta‑analysis.2020International Journal of Clinical Oncology
Darolutamide (Nubeqa) nmCRPC – Final clinical guidance report. 2020CADTH
New hormonal agents in patients with nonmetastatic castration-resistant prostate cancer: meta-analysis of efficacy and safety outcomes. 2019Clinical Genitourinary Cancer

Clinical Practice Guidelines

Document TitleYearSource
Advanced prostate cancer: AUA/ASTRO/SUO guideline. 2023American Urological Association Education and Research
Prostate cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up.2020Annals of Oncology