PHARMACYCLICS LLC — Imbruvica FDA Review (NDA/BLA 205552, 2017)
AbbVie Inc. · 2017 · FDA Review (Drugs@FDA) · company profile →
Report summary
The FDA approved Imbruvica (ibrutinib) for Mantle Cell Lymphoma (MCL) and Chronic Lymphocytic Leukemia (CLL), including CLL with 17p deletion. This approval, initially accelerated, was converted to full based on superior efficacy demonstrated in the Phase 3 PCYC-1112-CA trial, comparing ibrutinib to ofatumumab in relapsed/refractory CLL/SLL. Ibrutinib showed significantly improved progression-free survival, overall survival, and overall response rates. Key safety warnings include hemorrhage, infections, cytopenias, atrial fibrillation, and secondary malignancies. The report details dosage, administration, adverse event rates, pharmacokinetic properties, and regulatory history, including breakthrough therapy designation and postmarketing requirements.
Key findings — cited to the page
| Neutropenia (MCL, Grade 3 or 4) | 29 % | IMBRUVICA · p.15 |
| Thrombocytopenia (MCL, Grade 3 or 4) | 17 % | IMBRUVICA · p.15 |
| Grade 3 or 4 thrombocytopenia | 5 to 17 % | IMBRUVICA · p.13 |
| Grade 3 or 4 neutropenia | 23 to 29 % | IMBRUVICA · p.13 |
| Pneumonia (MCL, Grade 3 or 4) | 7 % | IMBRUVICA · p.15 |
| Skin infections (MCL, Grade 3 or 4) | 5 % | IMBRUVICA · p.15 |
| Bleeding events of any grade | approximately half of patients | IMBRUVICA · p.13 |
| Grade 3 or higher bleeding events | 6 % | IMBRUVICA · p.12 |
| Infections Grade 3 or greater (MCL) | 25 % | IMBRUVICA · p.13 |
| Infections Grade 3 or greater (CLL) | 26 % | IMBRUVICA · p.13 |
| Grade 3 or 4 anemia | 0 to 9 % | IMBRUVICA · p.13 |
| Anemia (MCL, Grade 3 or 4) | 9 % | IMBRUVICA · p.15 |
Source: AbbVie Inc. ↗ · 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 →