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 multiple indications, including MCL, WM, MZL, and CLL/SLL, with accelerated approval for MCL and MZL contingent on confirmatory trials. This report details Brukinsa's comprehensive safety and efficacy profiles across various B-cell malignancies, drawing from numerous clinical trials (e.g., ALPINE, SEQUOIA). Efficacy outcomes, such as superior objective response rates and progression-free survival, were demonstrated against comparators like ibrutinib and bendamustine + rituximab. The safety profile, consistent across studies, highlights common adverse events (hemorrhage, infections, cytopenias, second primary malignancies, cardiac arrhythmias) and generally favorable discontinuation rates compared to other treatments. Dosage, modifications, drug interactions, and patient counseling information are also provided. While efficacy data is robust, the FDA noted concerns regarding the immaturity of overall survival data for CLL/SLL, particularly in treatment-naïve patients.
Key findings — cited to the page
| rash (all grades, WM Cohort 1, Ibrutinib) | 32 % | · p.21 |
| musculoskeletal pain (all grades, WM Cohort 1, BRUKINSA) | 45 % | · p.21 |
| bruising (all grades, WM Cohort 1, Ibrutinib) | 34 % | · p.21 |
| rash (all grades, WM Cohort 1, BRUKINSA) | 29 % | · p.21 |
| fatigue (all grades, WM Cohort 1, Ibrutinib) | 25 % | · p.21 |
| pruritus (all grades, WM Cohort 1, BRUKINSA) | 11 % | · p.21 |
| pyrexia (all grades, WM Cohort 1, BRUKINSA) | 16 % | · p.21 |
| pyrexia (all grades, WM Cohort 1, Ibrutinib) | 13 % | · p.21 |
| edema peripheral (all grades, WM Cohort 1, BRUKINSA) | 12 % | · p.21 |
| edema peripheral (all grades, WM Cohort 1, Ibrutinib) | 20 % | · p.21 |
| bruising (all grades, WM Cohort 1, BRUKINSA) | 20 % | · p.21 |
| musculoskeletal pain (all grades, WM Cohort 1, Ibrutinib) | 39 % | · p.21 |
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 →