PHARMACYCLICS LLC — Imbruvica FDA Review (NDA/BLA 205552, 2020)
AbbVie Inc. · 2020 · FDA Review (Drugs@FDA) · company profile →
Report summary
The FDA approved Imbruvica (ibrutinib) for chronic graft versus host disease (cGVHD) after failure of prior systemic therapy, effective August 8, 2017. This approval was based on a 66.7% overall response rate in the pivotal PCYC-1129-CA study. Imbruvica, an orally administered BTK inhibitor, also has indications for various B-cell malignancies. Common adverse reactions include neutropenia, thrombocytopenia, diarrhea, and fatigue. The report details dosage, modifications, warnings, and adverse reactions across all indications. While efficacy was demonstrated, the Lee cGVHD Symptom Scale was deemed unsuitable for labeling due to methodological concerns. Postmarketing requirements include further safety analysis in cGVHD patients.
Key findings — cited to the page
| Grade 3 or 4 thrombocytopenia | 5 to 17 % | IMBRUVICA · p.15 |
| Grade 3 or 4 Pneumonia | 10 % | Study 1102 · p.19 |
| Grade 3 or higher bleeding events | 6 % | IMBRUVICA · p.15 |
| Grade 3 or 4 neutropenia | 13 to 29 % | IMBRUVICA · p.15 |
| Grade 3 or 4 Diarrhea | 4 % | Study 1102 · p.19 |
| Grade 3 or 4 Upper respiratory tract infection | 2 % | Study 1102 · p.19 |
| Grade 3 or 4 Pneumonia | 6 % | Study 1118 · p.25 |
| Grade 3 atrial fibrillation events | 1 | PCYC-1129-CA · p.74 |
| Bleeding events of any grade | approximately half % | IMBRUVICA · p.15 |
| Grade 3 or greater infections | 14 to 29 % | IMBRUVICA · p.15 |
| Grade 3 or 4 anemia | 0 to 13 % | IMBRUVICA · p.15 |
| Grade 3 or 4 Fatigue | 6 % | Study 1102 · p.19 |
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 →