Drug updated on 11/1/2024
| 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).
Latest News
Summary
- This summary is based on the review of 19 systematic review(s)/meta-analysis(es). [1-19]
- Abiraterone acetate (AA) combined with androgen deprivation therapy (ADT) significantly improves overall survival (OS) in metastatic hormone-sensitive prostate cancer (mHSPC), with a hazard ratio (HR) of 1.568 (95% credible interval [CrI]: 1.378-1.773) for the general population, and HR of 1.164 (95% CrI: 1.348-1.924) for high-volume disease subgroups.
- In high-risk non-metastatic prostate cancer, AA combined with prednisolone significantly prolongs metastasis-free survival (MFS) compared to ADT alone, with an HR of 0.53 (95% confidence interval [CI]: 0.44-0.64, p<0.0001).
- The combination of AA with prednisolone also significantly improves prostate cancer-specific survival (PCSS) compared to ADT alone, yielding an HR of 0.49 (95% CI: 0.37-0.65, p<0.0001).
- Enzalutamide demonstrates superior prostate-specific antigen progression-free survival (PSA-PFS) (HR=0.365, 95% CI: 0.303-0.441) and time to PSA progression (TTPP) (HR=0.19, 95% CI: 0.17-0.22) compared to AA in metastatic castration-resistant prostate cancer (mCRPC) patients.
- Fracture Incidence: Patients receiving (223)Ra combined with abiraterone acetate (AA) showed a higher fracture incidence compared to non-hormonal anti-androgens (NHA) monotherapy (OR: 3.22, 95% CI: 2.24-4.63, P < 0.01).
- Adverse Events: The combination of AA with androgen deprivation therapy (ADT) is associated with an increased risk of grade III to V adverse events (RR 1.34, 95% CI 1.22 to 1.47), including more frequent occurrences of hypertension and alanine transaminitis.
- Serious Adverse Events (SAEs): There was no significant difference in the incidence of SAEs between abiraterone and enzalutamide in metastatic castration-resistant prostate cancer (mCRPC) (P=0.21, I(2 =) 38%).
- There is no population-type or subgroup information available in the reviewed studies.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Zytiga (abiraterone acetate) Prescribing Information. | 2021 | Janssen Biotech, Inc., Titusville, NJ |