JANSSEN BIOTECH — Zytiga FDA Review (NDA/BLA 202379, 2016)
Johnson & Johnson · 2016 · FDA Review (Drugs@FDA) · company profile →
Report summary
The FDA approved Janssen Biotech's Zytiga (abiraterone acetate) for metastatic castration-resistant prostate cancer (mCRPC), including chemotherapy-naive patients, based on trials like COU-AA-302. Zytiga significantly improved radiographic progression-free survival (rPFS) and showed a strong trend in overall survival (OS). Efficacy endpoints consistently favored abiraterone, including time to cytotoxic chemotherapy and pain-related measures. Safety data revealed common adverse events like mineralocorticoid-related effects, hepatotoxicity, and cardiotoxicity, with a slightly higher incidence of deaths in the abiraterone arm. Dosage modifications for hepatic impairment and administration on an empty stomach are crucial. Nonclinical studies also noted reproductive and developmental toxicities. The approval package details indications, warnings, adverse reactions, and postmarketing requirements.
Key findings — cited to the page
| Grade 3 to 4 edema | 1 % | · p.11 |
| Grade 3-4 Muscle discomfort (ZYTIGA arm, Study 1) | 3.0 % | Study 1 · p.15 |
| Grade 3 to 4 hypertension | 2 % | · p.11 |
| Grade 3 to 4 hypokalemia | 4 % | · p.11 |
| Grade 3 or 4 ALT or AST increases | 4 % | · p.12 |
| Grade 3-4 Joint swelling/discomfort (ZYTIGA arm, Study 1) | 4.2 % | Study 1 · p.15 |
| Bilirubin Grade 1-4 | 5 % | COU-AA-302 · p.178 |
| Bilirubin Grade 3-4 | 0.2 % | COU-AA-302 · p.178 |
| Hypokalemia Grade 3-4 | 2 % | COU-AA-302 · p.178 |
| Hyperkalemia Grade 1-4 | 5 % | COU-AA-302 · p.178 |
| Hyperkalemia Grade 3-4 | 0.2 % | COU-AA-302 · p.178 |
| Grade 3-4 Edema (ZYTIGA arm, Study 1) | 1.9 % | Study 1 · p.15 |
Source: Johnson & Johnson ↗ · License: US Government public domain. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Oncology library →