Johnson & Johnson — Zytiga EMA EPAR public assessment report (EMEA/H/C/002321, 2011)
Johnson & Johnson · 2011 · EMA EPAR public assessment report · company profile →
Report summary
The EMA's assessment of Zytiga (abiraterone) for metastatic castration-resistant prostate cancer (mCRPC) led to its marketing authorization. Zytiga, an irreversible CYP17 inhibitor, demonstrated potent anti-tumor activity in preclinical models by reducing androgen synthesis. Toxicological studies showed dose-dependent effects on reproductive organs and hormone levels, consistent with its mechanism. The pivotal Phase 3 COU-AA-301 trial, conducted in docetaxel-pretreated mCRPC patients, showed significant improvements in overall survival, time to PSA progression, and radiographic progression-free survival compared to placebo. Secondary endpoints like pain palliation also favored abiraterone. Safety analysis revealed common adverse events, mineralocorticoid-related toxicities (fluid retention, hypokalemia), and cardiac disorders. While risks like cardiac events, urinary infections, and hepatotoxicity were identified, the overall benefit-risk balance for Zytiga in combination with prednisone/prednisolone was deemed positive. The application underwent accelerated assessment.
Key findings — cited to the page
| Grade 3 or 4 AST increase incidence (abiraterone acetate group) | 1 % | · p.62 |
| Grade 3 atrial fibrillation incidence (placebo group) | 0.5 % | COU-AA-301 · p.61 |
| Grade 3 or 4 ALP increase incidence (placebo group) | 2 % | · p.62 |
| Grade 3 or 4 hypokalaemia incidence (abiraterone acetate group) | 3.8 % | COU-AA-301 · p.61 |
| Grade 3 hypertension incidence (placebo group) | 0.3 % | COU-AA-301 · p.61 |
| Grade 3 atrial fibrillation incidence (abiraterone acetate group) | 0.6 % | COU-AA-301 · p.61 |
| Grade 3 or 4 hypokalaemia incidence (placebo group) | 0.8 % | COU-AA-301 · p.61 |
| Grade 3 or 4 ALP increase incidence (abiraterone acetate group) | 1 % | · p.62 |
| Grade 3 or 4 peripheral oedema incidence (abiraterone acetate group) | 1.5 % | COU-AA-301 · p.61 |
| Grade 3 or 4 peripheral oedema incidence (placebo group) | 0.8 % | COU-AA-301 · p.61 |
| Grade 3 hypertension incidence (abiraterone acetate group) | 1.3 % | COU-AA-301 · p.61 |
| Grade 3 or 4 AST increase incidence (placebo group) | 1 % | · p.62 |
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