Drug updated on 4/10/2024
| Dosage Form | Film-coated tablet (oral; 500 mg); uncoated tablet (oral; 250 mg) |
| Drug Class | CYP17 inhibitors |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer (CRPC).
- Indicated in combination with prednisone for the treatment of patients with metastatic high-risk castration-sensitive prostate cancer (CSPC).
Summary
- Abiraterone acetate (Zytiga) is indicated in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer (CRPC) and those with metastatic high-risk castration-sensitive prostate cancer (CSPC).
- A comprehensive analysis was conducted on 16 systematic reviews/meta-analyses, focusing on Zytiga's safety, effectiveness, and comparative performance against other medications.
- The risk of cognitive impairment associated with Zytiga use is moderate compared to other novel hormonal agents; it showed a relatively lower risk ratio than enzalutamide but higher than darolutamide.
- Real-world outcomes indicate similar survival, safety, and economic results between Zytiga and enzalutamide for first-line metastatic CRPC treatment. Evidence suggested improvements in health-related quality of life with abiraterone.
- In non-metastatic CRPC cases, Zytiga displayed significant efficacy, showing the lowest hazard of metastasis and death compared to placebo and similar medications but had the highest odds of serious adverse events.
- Efficacy and safety profiles were consistent among Asian patients, suggesting no racial or ethnic limitations in its efficacy or safety profile when treating advanced/metastatic prostate cancer using Zytiga.
- When combined with prednisolone, Zytiga improved several aspects such as overall survival rates significantly more than ADT alone, indicating its strength in a combination therapy setting, especially for high-risk Non-Metastatic Prostate Cancer.
- Zytiga administered as first-line treatment followed by enzalutamide has shown significant clinical efficacy according to sequencing studies, which indicates the strategic planning importance during treatments.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Zytiga (abiraterone acetate) Prescribing Information. | 2021 | Janssen Biotech, Inc., Horsham, PA |