BeOne Medicines Ltd. — Brukinsa FDA Review (NDA/BLA 213217, 2024)
BeOne Medicines Ltd. · 2024 · FDA Review (Drugs@FDA) · company profile →
Report summary
The FDA approved BRUKINSA (zanubrutinib) for Mantle Cell Lymphoma (MCL) and Waldenström’s Macroglobulinemia (WM). This report details its approval, dosage, warnings (hemorrhage, infections, cardiac arrhythmias), and postmarketing commitments. Efficacy data from the ASPEN study showed a 77.5% overall response rate in WM, comparable to ibrutinib, and a favorable safety profile with lower discontinuation rates. While the primary endpoint of superiority in WM was not met, BRUKINSA offers a new treatment option with improved safety compared to existing therapies. Pharmacokinetic and exposure-response analyses supported its use.
Key findings — cited to the page
| Grade 3 or 4 thrombocytopenia rate | 11 % | BRUKINSA monotherapy · p.17 |
| Grade 3 or higher atrial fibrillation and atrial flutter rate | 0.8 % | BRUKINSA monotherapy · p.17 |
| Any grade hemorrhage rate | 35 % | BRUKINSA monotherapy · p.16 |
| Grade 3 or 4 neutropenia rate | 28 % | BRUKINSA monotherapy · p.17 |
| Grade 4 neutropenia rate | 13 % | · p.17 |
| Grade 4 thrombocytopenia rate | 4 % | · p.17 |
| nausea (Ibrutinib, all grades) | 13 % | ASPEN Cohort 1 · p.22 |
| Grade 3 or higher hemorrhage rate | 3.0 % | BRUKINSA monotherapy · p.16 |
| Grade 3 or higher infections rate | 28 % | BRUKINSA monotherapy · p.17 |
| Grade 3 or higher pneumonia rate | most common | · p.17 |
| Grade 3 or 4 anemia rate | 7 % | BRUKINSA monotherapy · p.17 |
| neutropenia and neutrophil count decreased (all grades) | 38 % | · p.20 |
Source: BeOne Medicines Ltd. ↗ · 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 →