PHARMACYCLICS LLC — Imbruvica FDA Review (NDA/BLA 205552, 2017)
AbbVie Inc. · 2017 · FDA Review (Drugs@FDA) · company profile →
Report summary
This FDA approval package details Imbruvica (ibrutinib)'s efficacy and safety for chronic lymphocytic leukemia (CLL) and mantle cell lymphoma (MCL), including CLL with 17p deletion. Clinical trial PCYC-1112-CA demonstrated ibrutinib's superiority over ofatumumab in CLL, showing significantly improved progression-free survival, overall survival, and overall response rates. While ibrutinib had higher rates of certain adverse events like hemorrhage and infections, it received regulatory designations including Breakthrough Therapy. The report outlines approved indications, dosage, warnings, and postmarketing requirements, confirming ibrutinib's robust benefit and full approval for CLL.
Key findings — cited to the page
| Grade 3 or 4 anemia | 0 to 9 % | Imbruvica · p.13 |
| Grade 3 or 4 neutropenia (MCL) | 29 % | Imbruvica · p.15 |
| Infections Grade 3 or greater (MCL) | 25 % | Imbruvica · p.13 |
| Grade 3 or 4 thrombocytopenia | 5 to 17 % | Imbruvica · p.13 |
| Grade 3 or 4 skin infections (MCL) | 5 % | Imbruvica · p.15 |
| Grade 3 or 4 thrombocytopenia (MCL) | 17 % | Imbruvica · p.15 |
| Grade 3 or higher bleeding events | 6 % | Imbruvica · p.12 |
| Bleeding events of any grade | approximately half of patients | Imbruvica · p.13 |
| Infections Grade 3 or greater (CLL) | 26 % | Imbruvica · p.13 |
| Grade 3 or 4 neutropenia | 23 to 29 % | Imbruvica · p.13 |
| Grade 3 or 4 pneumonia (MCL) | 7 % | Imbruvica · p.15 |
| Grade 3 or 4 anemia (MCL) | 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 →