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Darolutamide

(Nubeqa®)

Darolutamide

Drug updated on 4/18/2024

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

Indication

  • Indicated for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC).
  • Indicated for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC) in combination with docetaxel.

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), often in combination with docetaxel.
  • A total of 26 studies were reviewed, providing a comprehensive comparison of darolutamide's efficacy and safety against other systemic therapies available for nmCRPC and mHSPC.
  • Studies highlight that darolutamide demonstrates significant improvement in overall survival (OS) and metastasis-free survival (MFS) compared to ADT alone or placebo, especially when used alongside docetaxel.
  • In high-volume mHSPC patients, the combination therapy involving darolutamide was associated with better OS and progression-free survival than single-agent systemic therapies based on ADT.
  • Darolutamide has been identified as having a top-ranking regimen for improving OS among treatments analyzed for mHSPC, indicating its potential effectiveness in managing advanced cases.
  • The drug also exhibits a favorable safety profile; it is well-tolerated across studies, which makes it beneficial particularly to those patients who have considerations such as cardiovascular function or bone health issues.
  • Compared directly to other systemic therapies, fewer severe adverse events are associated with darolutamide, leading to lower rates of treatment discontinuation due to its tolerability.
  • The efficacy and safety data support a personalized treatment approach where this drug could be tailored according to patient-specific factors like poor performance status (PS), different volumes of disease, etc., thus optimizing outcomes.

Product Monograph / Prescribing Information

Document TitleYearSource
Nubeqa (darolutamide) Prescribing Information.2023Bayer HealthCare Pharmaceuticals Inc., Whippany, NJ

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Impact of performance status on efficacy of systemic therapy for prostate cancer: a meta-analysis.2023BJU International
Systemic therapies for high-volume metastatic hormone-sensitive prostate cancer: a network meta-analysis.2023Acta Oncologica
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
Efficacy of systemic treatment in prostate cancer patients with visceral metastasis: a systematic review, meta-analysis, and network meta-analysis.2023The Journal of Urology
Triplet or doublet therapy in metastatic hormone-sensitive prostate cancer: updated network meta-analysis stratified by disease volume.2023European Urology Focus
First-line systemic treatment options for metastatic castration-sensitive prostate cancer: a living systematic review and network meta-analysis.2023JAMA Oncology
Comparative efficacy of second-generation androgen receptor inhibitors for treating prostate cancer: a systematic review and network meta-analysis.2023Frontiers in Endocrinology
Comparison of doublet and triplet therapies for metastatic hormone-sensitive prostate cancer: a systematic review and network meta-analysis.2023Frontiers in Oncology
The efficacy and adverse events of conventional and second-generation androgen receptor inhibitors for castration-resistant prostate cancer: a network meta-analysis.2023Frontiers in Endocrinology
Risk of cognitive impairment in men with advanced prostate cancer treated with NHAs: a systematic review and network meta-analysis.2023Clinical and Translational Science
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
Treatments for metastatic hormone-sensitive prostate cancer: systematic review, network meta-analysis, and benefit-harm assessment.2022European Urology Oncology
Systemic triplet therapy for metastatic hormone-sensitive prostate cancer: A systematic review and network meta-analysis.2022Frontiers in Pharmacology
Addition of androgen receptor-targeted agents to androgen-deprivation therapy and docetaxel in metastatic hormone-sensitive prostate cancer: a systematic review and meta-analysis.2022ESMO Open
Impact of new systemic therapies in overall survival in non-metastatic castration resistant prostate cancer: systematic review and meta-analysis.2022Clinical Genitourinary Cancer
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
Androgen receptor axis-targeted agents for non-metastatic castration-resistant prostate cancer impact on overall survival and safety profile: an updated systematic review and meta-analysis.2021Minerva Urology and Nephrology
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
Evaluation of cognitive function in trials testing new-generation hormonal therapy in patients with prostate cancer: a systematic review.2020Cancers
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
Updated treatment recommendations for prostate cancer from the ESMO clinical practice guideline considering treatment intensification and use of novel systemic agents.2023Annals of Oncology
Advanced prostate cancer: AUA/ASTRO/SUO guideline. 2020American Urological Association Education and Research
Prostate cancer: ESMO clinical practice guidelines for diagnosis, treatment and follow-up.2020Annals of Oncology