Drug updated on 9/4/2024
| 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).
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Summary
- Zytiga (abiraterone acetate) is indicated in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer (CRPC) and metastatic high-risk castration-sensitive prostate cancer (CSPC).
- This summary is based on the review of 17 systematic review(s)/meta-analysis(es). [1-17]
- Abiraterone acetate demonstrated the lowest hazard of metastasis and death in non-metastatic castration-resistant prostate cancer (nmCRPC), with darolutamide showing the lowest hazard of death.
- Median progression-free survival (PFS) in metastatic castration-resistant prostate cancer (mCRPC) ranged from 3.7 to 20.9 months, and overall survival (OS) ranged from 9.8 to 45 months, with survival outcomes being similar across treatments.
- First-line therapies in metastatic castration-sensitive prostate cancer (mCSPC) showed abiraterone acetate plus prednisolone (AAP) combined with androgen deprivation therapy (ADT) had a hazard ratio (HR) of 0.63 for overall survival, while enzalutamide plus ADT had a HR of 0.40 for PFS.
- In advanced prostate cancer, clinical benefits regarding overall, disease-free, and metastasis-free survival were observed with AAP, enzalutamide, and radium-223 in Asian populations.
- Cognitive Impairment: Abiraterone acetate had an odds ratio (OR) of 1.64 for cognitive impairment compared to placebo/standard care.
- Serious Adverse Events (SAEs) in nmCRPC: Darolutamide had the lowest odds of serious adverse events, followed by enzalutamide, apalutamide, and abiraterone acetate.
- Safety in Asian Populations: Treatments were well tolerated, with no new safety signals identified in the Asian population.
- Clinical benefits and safety profiles for treatments like AAP, enzalutamide, and radium-223 in Asian populations were consistent with those observed in overall trial populations; for mHSPC, no significant difference in OS benefit from adding an ARSI to DOC + ADT between low- and high-volume disease; men with high-risk non-metastatic prostate cancer defined by specific criteria showed improved outcomes with abiraterone acetate and prednisolone; real-world data for mCRPC supported consistent effectiveness and tolerability across different patient populations.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Zytiga (abiraterone acetate) Prescribing Information. | 2021 | Janssen Biotech, Inc., Horsham, PA |