JANSSEN BIOTECH — Zytiga FDA Review (NDA/BLA 202379, 2018)
Johnson & Johnson · 2018 · FDA Review (Drugs@FDA) · company profile →
Report summary
Zytiga (abiraterone acetate) was approved for metastatic castration-resistant prostate cancer. This report summarizes its approval, labeling updates, and clinical data. Key information includes dosage, modifications for hepatic impairment, and drug interactions, particularly with CYP3A4 inhibitors and inducers. Adverse reactions like hypertension, hypokalemia, fluid retention, and hepatotoxicity are noted. Clinical trials demonstrated improved overall and radiographic progression-free survival. Safety reviews covered adverse event reporting and drug-drug interaction studies, leading to labeling recommendations. Correspondence between the FDA and Janssen addressed a supplemental NDA proposing USPI updates for CYP3A4 interactions and overdose information, including potential dosing frequency changes for patients on strong CYP3A4 inducers.
Key findings — cited to the page
| High AST (grade 3-4) | 3.1 % | Abiraterone · p.17 |
| High AST (grade 1-4) | 37.3 % | Abiraterone · p.17 |
| Hypernatremia (grade 3-4) | 0.4 % | Abiraterone · p.17 |
| Hypokalemia (grade 1-4) | 17.2 % | Abiraterone · p.17 |
| Hypernatremia (grade 1-4) | 32.8 % | Abiraterone · p.17 |
| Lymphopenia (grade 3-4) | 8.7 % | Abiraterone · p.17 |
| Hyperglycemia (grade 1-4) | 56.6 % | Abiraterone · p.17 |
| Hyperglycemia (grade 3-4) | 6.5 % | Abiraterone · p.17 |
| High ALT (grade 1-4) | 41.9 % | Abiraterone · p.17 |
| High ALT (grade 3-4) | 6.1 % | Abiraterone · p.17 |
| Hypokalemia (grade 3-4) | 2.8 % | Abiraterone · p.17 |
| grade 3 to 4 hypertension | 2 % | ZYTIGA · p.11 |
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 →