Drug updated on 5/17/2024
Dosage Form | Tablet (oral; 60 mg, 240 mg) |
Drug Class | Androgen 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.
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Summary
- 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 Title | Year | Source |
---|---|---|
Erleada (apalutamide) Prescribing Information. | 2023 | Janssen Biotech |