Apalutamide

(Erleada®)

Erleada®

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Drug updated on 5/17/2024

Dosage FormTablet (oral; 60 mg, 240 mg)
Drug ClassAndrogen receptor inhibitors
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for the treatment of patients with metastatic castration-sensitive prostate cancer.
  • Indicated for the treatment of patients with non-metastatic castration-resistant prostate cancer.

Summary
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  • Apalutamide (Erleada) is indicated for the treatment of individuals with metastatic castration-sensitive prostate cancer and non-metastatic castration-resistant prostate cancer. This medication has been associated with improved overall survival and failure-free survival in hormone-sensitive metastatic prostate cancer when added to Androgen Deprivation Therapy (ADT).
  • The information was derived from 27 systematic reviews, meta-analyses, and randomized controlled trials that investigated the efficacy and safety profiles of apalutamide.
  • Comparative effectiveness analyses among systemic therapies indicate that apalutamide significantly improves overall survival compared to ADT alone. However, its selection over similar agents like enzalutamide or docetaxel often depends on specific characteristics of the disease such as high-volume versus low-volume.
  • Regarding safety, apalutamide has been associated with an increased risk of cognitive impairments, fatigue, and falls, which necessitates careful consideration of individual factors during treatment.
  • Subgroup considerations reveal variations in drug efficacy based on the volume of the disease; certain combinations involving docetaxel showed improved outcomes for high-volume diseases, while an age-associated increase in risk factors was observed with second-generation antiandrogens.
  • Socioeconomic factors, along with regional practice patterns, influence real-world utilization, suggesting disparities in access could affect outcomes.
  • Direct comparisons between apalutamide and other AR inhibitors show nuanced differences; darolutamide might present a more favorable safety profile regarding adverse cardiovascular events whereas apalutamide may offer slight advantages in Metastasis-Free Survival (MFS) outcomes.
  • The synergy between treatment efficacy, adverse effect profiles, and patient-specific factors underscores the importance of tailored treatment approaches where individual characteristics guide therapeutic choices, optimizing outcomes and minimizing risks.

Product Monograph / Prescribing Information

Document TitleYearSource
Erleada (apalutamide) Prescribing Information.2023Janssen Biotech

Systematic Reviews / Meta-Analyses

Document TitleYearSource
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.2023Anti-Cancer Drugs
Systemic therapies for high-volume metastatic hormone-sensitive prostate cancer: a network meta-analysis. 2023Acta Oncologica
Does research from clinical trials in metastatic hormone-sensitive prostate cancer treatment translate into access to treatments for patients in the "real world"? A systematic review.2023European Urology Oncology
The optimal upfront therapy in metastatic hormone-sensitive prostate cancer: a network meta-analysis. 2023Journal of Cancer Research and Therapeutics
Association of second-generation antiandrogens with cognitive and functional toxic effects in randomized clinical trials: a systematic review and 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
First-line systemic treatment options for metastatic castration-sensitive prostate cancer: a living systematic review and network meta-analysis.2023JAMA 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
Correction: 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. 2023Prostate Cancer and Prostatic Diseases
Comparative efficacy of olaparib in combination with or without novel antiandrogens for treating metastatic castration-resistant prostate cancer.2023Frontiers in Endocrinology (Lausanne)
Combination therapy for high-volume versus low-volume metastatic hormone-sensitive prostate cancer: a systematic review and network meta-analysis.2023Frontiers in Pharmacology
Comparison of doublet and triplet therapies for metastatic hormone-sensitive prostate cancer: a systematic review and network meta-analysis.2023Frontiers 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. 2022Prostate Cancer and Prostatic Diseases
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
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
Comparison of systemic treatments for metastatic castration-sensitive prostate cancer: a systematic review and network meta-analysis. 2021JAMA Oncology
Seizures and neuropsychiatric toxicity in patients with non-metastatic crpc treated with new antiandrogens: systematic review and meta-analysis. 2021Oncology Research and Treatment
Overall survival after systemic treatment in high-volume versus low-volume metastatic hormone-sensitive prostate cancer: systematic review and network meta-analysis. 2021European Urology Focus
Neoadjuvant treatment with androgen receptor signaling inhibitors prior to radical prostatectomy: a systematic review. 2021World Journal of Urology
Comparison of treatments for nonmetastatic castration-resistant prostate cancer: matching-adjusted indirect comparison and network meta-analysis. 2021Journal of the National Cancer Institute
Apalutamide, darolutamide and enzalutamide in nonmetastatic castration-resistant prostate cancer: a meta-analysis. 2021Future Oncology
Systemic therapies for metastatic hormone-sensitive prostate cancer: network meta-analysis. 2021BJU International
Risk of cardiovascular toxicities and hypertension in nonmetastatic castration-resistant prostate cancer patients treated with novel hormonal agents: a systematic review and meta-analysis. 2021Expert Opinion on Drug Metabolism & Toxicology
Comparative efficacy of apalutamide darolutamide and enzalutamide for treatment of non-metastatic castrate-resistant prostate cancer: a systematic review and network meta-analysis.2020Urologic 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
Apalutamide, enzalutamide, and darolutamide for non-metastatic castration-resistant prostate cancer: a systematic review and network meta-analysis.2020International Journal of Clinical Oncology
First-line systemic therapy for metastatic castration-sensitive prostate cancer: an updated systematic review with novel findings. 2020Critical Reviews in Oncology/Hematology

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