Enzalutamide

(Xtandi®)

Enzalutamide

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Drug updated on 4/15/2024

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

Summary
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  • Enzalutamide (Xtandi) is used for the treatment of various stages of prostate cancer, demonstrating significant efficacy in terms of overall survival, progression-free survival, and prostate-specific antigen response rates. It has shown competitive or superior outcomes compared to other therapies such as abiraterone, apalutamide, and darolutamide.
  • The study was based on 27 systematic reviews/meta-analyses that provided extensive information about enzalutamide's comparative efficacy and safety in treating different types of prostate cancer.
  • In metastatic castration-resistant prostate cancer settings, enzalutamide alongside PARP inhibitors shows promising survival benefits, especially for patients with HRR/BRCA-positive mutations.
  • The drug's effectiveness appears consistent across subgroups defined by volume of disease (high-volume vs. low-volume), previous treatment exposure (docetaxel-naïve patients), and genetic markers like HRR/BRCA mutations.
  • While it improves survival outcomes, enzalutamide is associated with higher risks of certain adverse events including hypertension and fatigue when compared to other therapies like abiraterone or apalutamide; however, most side effects are manageable, indicating a tolerable safety profile overall.
  • Compared directly to other AR-targeting agents, enzalutamide's side-effect profile includes a noteworthy risk for cardiovascular issues such as hypertension, which necessitates close monitoring. Darolutamide may have a more favorable safety profile particularly in non-metastatic castration-resistant prostate cancer settings, suggesting patient-specific risk factors should influence treatment choice.
  • Real-world evidence suggests similar survival profiles between enzalutamide and abiraterone but also highlights an unmet need for more effective treatments in metastatic CRPC due to room for improvement regarding managing adverse events and enhancing quality of life.
  • Bipolar Androgen Therapy appears safe and effective, offering a novel approach to resensitize patients to subsequent endocrine therapies after they have progressed on abiraterone or enzalutamide.

Product Monograph / Prescribing Information

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

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Efficacy and safety of bipolar androgen therapy in castration-resistant prostate cancer following abiraterone or enzalutamide resistance: a systematic review. 2023Frontiers in Endocrinology
The optimal upfront therapy in metastatic hormone-sensitive prostate cancer: a network meta-analysis. 2023Journal of cancer research and therapeutics
A systematic review and meta-analysis on overall survival, failure-free survival and safety outcomes in patients with metastatic hormone-sensitive prostate cancer treated with new anti-androgens. 2023Anticancer Drugs
Real-world outcomes for first line next-generation hormonal agents in metastatic prostate cancer: a systematic review. 2023Future Oncology
Efficacy and safety of therapies for advanced prostate cancer in Asia: evidence from a systematic literature review. 2023Therapeutic advances in Medical Oncology
Adverse events and androgen receptor signaling inhibitors in the treatment of prostate cancer: a systematic review and multivariate network meta-analysis.2023European Urology Oncology
Nonsurgical interventions to prevent disease progression in prostate cancer patients on active surveillance: a systematic review and meta-analysis2023European Urology Oncology
Poly (ADP-ribose) polymerase inhibitors in patients with metastatic castration-resistant prostate cancer: a meta-analysis of randomized controlled trials.2023Medicina (Kaunas)
A meta-analysis of randomized clinical trials assessing the efficacy of PARP inhibitors in metastatic castration-resistant prostate cancer.2023Current Oncology
Comparative efficacy of second-generation androgen receptor inhibitors for treating prostate cancer: a systematic review and network meta-analysis.2023Frontiers in Endocrinology
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
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.2022Minerva Urology and Nephrology
Association of novel androgen receptor axis-targeted therapies with diarrhea in patients with prostate cancer: a Bayesian network analysis.2022Frontiers in Medicine
Comparison of treatments for nonmetastatic castration-resistant prostate cancer: matching-adjusted indirect comparison and network meta-analysis. 2022Journal of the National Cancer Institute
A meta-analysis on overall survival and safety outcomes in patients with nonmetastatic castration-resistant prostate cancer treated with novel hormonal agents. 2022Anti-Cancer Drugs
Efficacy and safety of bipolar androgen therapy in mCRPC after progression on abiraterone or enzalutamide: a systematic review. 2022Urologic Oncology: Seminars and Original Investigations
Therapeutic sensitivity to standard treatments in BRCA positive metastatic castration-resistant prostate cancer patients—a systematic review and meta-analysis.2022Prostate Cancer Prostatic and Diseases
Quality of life in men with metastatic castration-resistant prostate cancer treated with enzalutamide or abiraterone: a systematic review and 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
Efficacy and safety of abiraterone acetate and enzalutamide for the treatment of metastatic castration-resistant prostate cancer: a systematic review and meta-analysis.2021Frontiers in Oncology
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
Apalutamide, enzalutamide, and darolutamide for non‑metastatic castration‑resistant prostate cancer: a systematic review and network meta‑analysis.2020International Journal of Clinical Oncology
Revealing the prognostic landscape of neutrophil-to-lymphocyte ratio and platelet-to-lymphocyte ratio in metastatic castration resistant prostate cancer patients treated with abiraterone or enzalutamide: a meta-analysis. 2020Prostate Cancer and Prostatic Diseases
Comparing the clinical efficacy and safety of abiraterone and enzalutamide in metastatic castration-resistant prostate cancer: a systematic review and meta-analysis.2020Journal of Oncology Pharmacy Practice
Abiraterone and enzalutamide had different adverse effects on the cardiovascular system: a systematic review with pairwise and network meta-analyses.2020Prostate Cancer and Prostatic Diseases
Comparison of effectiveness and safety outcomes of abiraterone versus enzalutamide in patients with metastatic castration resistant prostate cancer: a systematic review and meta-analysis.2020Journal of Pharmacy and Pharmaceutical Sciences
Efficacy and safety of abiraterone and enzalutamide for castration-resistant prostate cancer.2019Medicine

Clinical Practice Guidelines