PHARMACYCLICS LLC â Imbruvica FDA Review (NDA/BLA 205552, 2021)
AbbVie Inc. · 2021 · FDA Review (Drugs@FDA) · company profile â
Report summary
The FDA approved IMBRUVICA (ibrutinib) capsules for Waldenströmâs macroglobulinemia (WM) on January 29, 2015, based on a supplemental new drug application. This approval was supported by a Phase 2, single-arm study (PCYC-1118E) in relapsed or refractory WM patients, demonstrating an overall response rate of 61.9-83% and a favorable benefit-risk profile. The drug's efficacy and safety were consistent with its known profile in other indications like Mantle Cell Lymphoma and Chronic Lymphocytic Leukemia. Key safety concerns include hemorrhagic events, infections, and cardiac arrhythmias, with dosage adjustments recommended for hepatic impairment and drug interactions. The approval addressed a significant unmet need for WM, a rare and incurable disease.
Key findings â cited to the page
| Treatment-emergent Grade 3 or 4 anemia | 0 to 9 % | IMBRUVICA · p.13 |
| Nausea (All Grades) in MCL trial | 31 % | IMBRUVICA · p.16 |
| Bleeding events of any grade | approximately half of patients | IMBRUVICA · p.13 |
| Treatment-emergent Grade 3 or 4 thrombocytopenia | 5 to 17 % | IMBRUVICA · p.13 |
| Diarrhea (Grade 3 or 4) in MCL trial | 5 % | IMBRUVICA · p.16 |
| Diarrhea (All Grades) in MCL trial | 51 % | IMBRUVICA · p.16 |
| Constipation (Grade 3 or 4) in MCL trial | 0 % | IMBRUVICA · p.16 |
| Grade 3 or higher bleeding events | 6 % | IMBRUVICA · p.13 |
| Grade 3 or greater infections | 14 to 26 % | IMBRUVICA · p.13 |
| Treatment-emergent Grade 3 or 4 neutropenia | 19 to 29 % | IMBRUVICA · p.13 |
| Most common Grade 3 or 4 non-hematological adverse reactions (℠5%) in MCL trial | pneumonia, abdominal pain, atrial fibrillation, diarrhea, fatigue, and skin infections | IMBRUVICA · p.15 |
| Nausea (Grade 3 or 4) in MCL trial | 0 % | IMBRUVICA · p.16 |
Source: AbbVie Inc. â · License: US Government public domain. Summary and findings are extracted from the published document; every figure cites its page. Informational only â not investment advice. Explore the Oncology library â