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.

Latest News

loading GIF

Summary
This AI-generated content is provided without warranty, with no liability accepted for reliance on it. Learn more.

  • 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