Current best evidence on prescribed drugs

Pills
Drugdocs Logo

Current best evidence on prescribed drugs

Pills
HomeDrugsNewsAboutContact

DRUG ▾

ABCDEFGHIJKLMNOPQRSTUVWXYZ

DRUG

CLASS

News

Apalutamide

(Erleada®)

Erleada®

Drug updated on 3/28/2024

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

Indication

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

Summary
This AI-generated content is provided without warranty and may be inaccurate or outdated; it should be used only as a research starting point, with no liability accepted for reliance on it. Learn more.

  • Apalutamide (Erleada) is indicated for the treatment of patients with metastatic castration-sensitive prostate cancer and non-metastatic castration-resistant prostate cancer.
  • A review of 26 systematic reviews/meta-analyses reveals that apalutamide, when added to androgen deprivation therapy (ADT), significantly improves metastasis-free survival, overall survival, and prostate-specific antigen progression-free survival over ADT alone.
  • Compared directly or indirectly in network meta-analyses with other ARAT agents like enzalutamide and darolutamide as well as docetaxel, apalutamide shows similar efficacy but occasionally emerges as a preferred option based on its impact on metastasis-free survival in non-metastatic castration-resistant prostate cancer.
  • Despite its effectiveness, apalutamide has been associated with an increased risk of adverse events including grade 3+ events; incidences of hypertension and fatigue were notably higher compared to placebo or older agents such as bicalutamide.
  • The safety profile varies among patient subgroups: studies indicate better outcomes from NSAAs among patients with Eastern Cooperative Oncology Group performance status 0 than those at status 1; also the volume of disease influences therapy effectiveness - high-volume vs low-volume mCSPC cases show variable results.
  • Drug selection appears influenced by tolerability/safety considerations along with comorbid conditions; while prolonging MFS & OS are critical factors guiding therapeutic choices so too are potential adverse effects especially cardiovascular risks & higher-grade toxicities related to specific drugs like apulatimide.
  • In terms of population types/subgroup considerations: abiraterone often ranks highly for high-volume mHSPC indicating that volume status might play a crucial role in choosing appropriate treatment strategy; younger patients having better performance statuses seem more likely to benefit from newer treatments including use of apalutamide.
  • Darolutamide, another ARAT agent, emerges as a contender with a better tolerance profile which could be especially valuable for patients at higher risk of adverse effects; the ultimate choice among apalutamide and other agents should be influenced by thorough assessment of disease characteristics, patient health status & potential AEs along with overall goal of therapy.

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
Immune checkpoint inhibitor- and phosphatidylinositol-3-kinase inhibitor-related diabetes induced by antineoplastic drugs: two case reports and a literature review. 2023Frontiers in Endocrinology
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. 2023The optimal upfront therapy in metastatic hormone-sensitive prostate cancer: A network meta-analysis.
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
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
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
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
Apalutamide with androgen deprivation therapy for treating high-risk hormone-relapsed non-metastatic prostate cancer.2021NICE
Apalutamide with androgen deprivation therapy for treating hormone-sensitive metastatic prostate cancer.2021NICE
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
Final clinical guidance report: apalutamide (Erleada) for metastatic castration-sensitive prostate cancer.2020CADTH
Antiandrogen therapies for nonmetastatic castration-resistant prostate cancer: effectiveness and value. 2018ICER
Final clinical guidance report: apalutamide (Erleada) for castration-resistant prostate cancer. 2018CADTH
Management of non-metastatic castrate-resistant prostate cancer: a systematic review. 2018Cancer Treatment Reviews

Clinical Practice Guidelines

Document TitleYearSource
EAU-EANM-ESTRO-ESUR-ISUP-SIOG: guidelines on prostate cancer. 2022European Association of Urology
Initial management of noncastrate advanced, recurrent, or metastatic prostate cancer: ASCO guideline update. 2021Journal of Clinical Oncology
Advanced prostate cancer: AUA/ASTRO/SUO guideline.2021The Journal of Urology
Optimizing outcomes for patients with metastatic prostate cancer: insights from South East Asia expert panel. 2021Therapeutic Advances in Medical Oncology
Advanced/metastatic prostate cancer.2021Alberta Health Services
Prostate cancer: ESMO clinical practice guidelines for diagnosis, treatment and follow-up. 2020Annals of Oncology
Factors to Guide Treatment Selection for Hormone-Sensitive Metastatic Prostate Cancer. 2020Cancer Journal