Enzalutamide

(Xtandi®)

Enzalutamide

Drug updated on 12/11/2024

Dosage FormCapsule (oral; 40 mg); Tablet (oral; 40 mg, 80 mg)
Drug ClassAndrogen receptor inhibitors
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for the treatment of patients with castration-resistant prostate cancer
  • Indicated for the treatment of patients with metastatic castration-sensitive prostate cancer
  • Indicated for the treatment of patients with non-metastatic castration-sensitive prostate cancer with biochemical recurrence at high risk for metastasis.

Latest News

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Summary
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  • This summary is based on the review of 48 systematic review(s)/meta-analysis(es). [1-48]
  • Metastasis-Free Survival (MFS): Enzalutamide combined with androgen deprivation therapy (ADT) significantly improved MFS in non-metastatic castration-resistant prostate cancer (nmCRPC) compared to ADT alone and outperformed other hormone-based strategies.
  • Overall Survival (OS): Enzalutamide + ADT showed the greatest OS benefit among hormone-based strategies; however, no significant differences in OS were observed between enzalutamide and other androgen receptor inhibitors (ARIs) like apalutamide and darolutamide in metastatic castration-resistant prostate cancer (mCRPC).
  • Progression-Free Survival (PFS): Enzalutamide demonstrated high efficacy in enhancing PFS versus placebo in nmCRPC and showed favorable PFS outcomes compared to docetaxel and abiraterone.
  • Prostate-Specific Antigen (PSA) Progression-Free Survival: Enzalutamide was effective in improving PSA-PFS in both metastatic and non-metastatic settings, highlighting its broad utility in managing prostate cancer.
  • Enzalutamide is associated with an increased risk of grade ≥3 atrial fibrillation and hypertension, as well as a higher incidence of fatigue and significant neuropsychiatric effects, including dizziness and mental impairment, compared to other androgen receptor inhibitors (ARIs) like darolutamide.
  • In terms of serious adverse events, enzalutamide has a comparable risk of grade ≥3 adverse events to other ARI therapies and is generally well-tolerated; however, it shows a higher risk for hypertension and atrial fibrillation compared to abiraterone.
  • Elderly patients (>75 years) experienced a higher incidence of neuropsychiatric side effects with enzalutamide, necessitating careful monitoring, particularly in those with preexisting cardiovascular conditions.
  • Enzalutamide demonstrated significant benefits in overall survival (OS) and progression-free survival (PFS) for both high-volume and low-volume metastatic hormone-sensitive prostate cancer (mHSPC) patients, with elderly patients (>75 years) experiencing improved long-term health-related quality of life (HRQoL); however, increased cardiovascular risks necessitate vigilant monitoring in patients with preexisting cardiovascular conditions.

Product Monograph / Prescribing Information

Document TitleYearSource
Xtandi (enzalutamide) Prescribing Information.2023Astellas Pharma US, Inc., Northbrook, IL

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Salvage therapies for biochemical recurrence after definitive local treatment: a systematic review, meta-analysis, and network meta-analysis2024Prostate Cancer and Prostatic Diseases
Cardiovascular events among men with prostate cancer treated with androgen receptor signaling inhibitors: a systematic review, meta-analysis, and network meta-analysis2024Prostate Cancer and Prostatic Diseases
Cardiovascular Events and Androgen Receptor Signaling Inhibitors in Advanced Prostate Cancer: A Systematic Review and Meta-Analysis2024JAMA Oncology
Evaluating first-line therapeutic strategies for metastatic castration-resistant prostate cancer: a comprehensive network meta-analysis and systematic review2024Frontiers in Oncology
Role of enzalutamide in primary and recurrent non-metastatic hormone sensitive prostate cancer: a systematic review of prospective clinical trials2024Prostate Cancer and Prostatic Diseases
Cost-effectiveness and budget impact analysis of enzalutamide in comparison to abiraterone in treatment of metastatic prostate cancer resistant to castration in Iran2024BMC Urology
Nonsurgical Interventions to Prevent Disease Progression in Prostate Cancer Patients on Active Surveillance: A Systematic Review and Meta-analysis2024European Urology Oncology
Health-related quality of life in patients with metastatic hormone-sensitive prostate cancer treated with androgen receptor signaling inhibitors: the role of combination treatment therapy2024Prostate Cancer and Prostatic Diseases
Poly (ADP-ribose) Polymerase Inhibitors in Patients with Metastatic Castration-Resistant Prostate Cancer: A Meta-Analysis of Randomized Controlled Trials2023Medicina (Kaunas, Lithuania)
A Meta-Analysis of Randomized Clinical Trials Assessing the Efficacy of PARP Inhibitors in Metastatic Castration-Resistant Prostate Cancer2023Current Oncology
Combination therapy for high-volume versus low-volume metastatic hormone-sensitive prostate cancer: A systematic review and network meta-analysis2023Frontiers in Pharmacology
Comparison of doublet and triplet therapies for metastatic hormone-sensitive prostate cancer: A systematic review and network meta-analysis2023Frontiers in Oncology
First-line Systemic Treatment Options for Metastatic Castration-Sensitive Prostate Cancer: A Living Systematic Review and Network Meta-analysis2023JAMA Oncology
The efficacy and adverse events of conventional and second-generation androgen receptor inhibitors for castration-resistant prostate cancer: A network meta-analysis2023Frontiers in Endocrinology
Efficacy and safety of therapies for advanced prostate cancer in Asia: Evidence from a systematic literature review2022Therapeutic Advances in Medical Oncology
Survival modelling and cost-effectiveness analysis of treatments for newly diagnosed metastatic hormone-sensitive prostate cancer2022Plos One
Androgen annihilation versus advanced androgen blockage as first line treatment for metastatic castration resistant prostate cancer: A systematic review and meta-analysis2022Critical Reviews in Oncology/Hematology
Androgen Receptor Signaling Inhibitors in Addition to Docetaxel with Androgen Deprivation Therapy for Metastatic Hormone-sensitive Prostate Cancer: A Systematic Review and Meta-analysis2022European Urology
Chemotherapy and advanced androgen blockage, alone or combined, for metastatic hormone-sensitive prostate cancer a systematic review and meta-analysis2022Cancer Treatment Reviews
Matching-adjusted indirect treatment comparison of the efficacy of enzalutamide versus apalutamide for the treatment of nonmetastatic castration-resistant prostate cancer2022ESMO Open
Statin and metformin use and outcomes in patients with castration-resistant prostate cancer treated with enzalutamide: A meta-analysis of AFFIRM, PREVAIL and PROSPER2022European Journal of Cancer
The Health Economics of Metastatic Hormone-Sensitive and Non-Metastatic Castration-Resistant Prostate Cancer-A Systematic Literature Review with Application to the Canadian Context2022Current Oncology
Cost-Effectiveness of Systemic Treatments for Metastatic Castration-Sensitive Prostate Cancer: An Economic Evaluation Based on Network Meta-Analysis2022Value in Health
Intensification of Systemic Therapy in Addition to Definitive Local Treatment in Nonmetastatic Unfavourable Prostate Cancer: A Systematic Review and Meta-analysis2022European Urology
Prognostic and Predictive Value of Liquid Biopsy-Derived Androgen Receptor Variant 7 (AR-V7) in Prostate Cancer: A Systematic Review and Meta-Analysis2022Frontiers in Oncology
Abiraterone acetate and prednisolone with or without enzalutamide for high-risk non-metastatic prostate cancer: a meta-analysis of primary results from two randomised controlled phase 3 trials of the STAMPEDE platform protocol2022Lancet (London, England)
Impact of New Systemic Therapies in Overall Survival in Non-Metastatic Castration Resistant Prostate Cancer: Systematic Review and Meta-Analysis2022Clinical Genitourinary Cancer
A meta-analysis on overall survival and safety outcomes in patients with nonmetastatic castration-resistant prostate cancer treated with novel hormonal agents2022Anti-Cancer Drugs
Androgen receptor axis-targeted agents for non-metastatic castration-resistant prostate cancer impact on overall survival and safety profile2022Minerva Urology and Nephrology
Systemic therapies for metastatic hormone-sensitive prostate cancer: network meta-analysis2022BJU International
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-analysis2022Prostate Cancer and Prostatic Diseases
Hormonal prostate cancer therapies and cardiovascular disease: a systematic review2022Heart Failure Reviews
Comparison of Systemic Treatments for Metastatic Castration-Resistant Prostate Cancer After Docetaxel Failure: A Systematic Review and Network Meta-analysis2021Frontiers in Pharmacology
Efficacy and Safety of Abiraterone Acetate and Enzalutamide for the Treatment of Metastatic Castration-Resistant Prostate Cancer: A Systematic Review and Meta-Analysis2021Frontiers in Oncology
(177)Lu-PSMA Radioligand Therapy Is Favorable as Third-Line Treatment of Patients with Metastatic Castration-Resistant Prostate Cancer. A Systematic Review and Network Meta-Analysis of Randomized Controlled Trials2021Biomedicines
Quality of life in men with metastatic castration-resistant prostate cancer treated with enzalutamide or abiraterone: a systematic review and meta-analysis2021Prostate Cancer and Prostatic Diseases
Seizures and Neuropsychiatric Toxicity in Patients with Non-Metastatic CRPC Treated with New Antiandrogens: Systematic Review and Meta-Analysis2021Oncology Research and Treatment
Apalutamide, darolutamide and enzalutamide in nonmetastatic castration-resistant prostate cancer: a meta-analysis2021Future Oncology (London, England)
Comparison of Systemic Treatments for Metastatic Castration-Sensitive Prostate Cancer: A Systematic Review and Network Meta-analysis2021JAMA Oncology
Systematic Review of Efficacy and Health Economic Implications of Real-world Treatment Sequencing in Prostate Cancer: Where Do the Newer Agents Enzalutamide and Abiraterone Fit in?2021European Urology Focus
Health-related Quality of Life in Patients with Advanced Prostate Cancer: A Systematic Review2021European Urology Focus
Comparative Efficacy of Combined Radiotherapy, Systemic Therapy, and Androgen Deprivation Therapy for Metastatic Hormone-Sensitive Prostate Cancer: A Network Meta-Analysis and Systematic Review2020Frontiers in Oncology
Comparison of Current Systemic Combination Therapies for Metastatic Hormone-Sensitive Prostate Cancer and Selection of Candidates for Optimal Treatment: A Systematic Review and Bayesian Network Meta-Analysis2020Frontiers in Oncology
Apalutamide, enzalutamide, and darolutamide for non-metastatic castration-resistant prostate cancer: a systematic review and network meta-analysis2020international Journal of Clinical Oncology
Comparative efficacy of apalutamide darolutamide and enzalutamide for treatment of non-metastatic castrate-resistant prostate cancer: A systematic review and network meta-analysis2020Urologic Oncology
Predictors of efficacy of androgen-receptor-axis-targeted therapies in patients with metastatic castration-sensitive prostate cancer: A systematic review and meta-analysis2020Critical Reviews in Oncology/Hematology
Systemic Management for Nonmetastatic Castration-resistant Prostate Cancer: A Systematic Review and Network Meta-Analysis2020American Journal of Clinical Oncology
Matching-Adjusted Indirect Comparison of the Efficacy of Apalutamide and Enzalutamide with ADT in the Treatment of Non-Metastatic Castration-Resistant Prostate Cancer2020Advances in Therapy

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