BeOne Medicines Ltd. — Brukinsa EMA EPAR variation assessment report (EMEA/H/C/004978, 2021)
BeOne Medicines Ltd. · 2021 · EMA EPAR variation assessment report · company profile →
Report summary
This report details the Type II variation approval for zanubrutinib (Brukinsa) to treat adult marginal zone lymphoma (MZL) patients previously treated with anti-CD20 therapy. Supported by pivotal studies BGB-3111-214 and BGB-3111-AU-003, the application demonstrated significant efficacy. Study BGB-3111-214 showed an Overall Response Rate of 68.2% and a Complete Response rate of 25.8%, with sustained efficacy indicated by unreached median Progression-Free Survival and Duration of Response. The recommended 320 mg daily dose (160 mg BID or 320 mg QD) was justified by safety, efficacy, and BTK occupancy data. The safety profile was consistent with known BTK inhibitors, with no new safety signals identified. The CHMP recommended approval, citing significant clinical benefit and granting an additional year of market protection. Environmental risk assessment updates were also included.
Key findings — cited to the page
| Daphnia sp. Reproduction Test (OECD 211) NOEC | 0.71 mg/L | · p.13 |
| Neutropenia (≥Grade 3) in MZL patients | 12.5 % | Studies 214+AU003 · p.121 |
| Haemorrhage (≥Grade 3) in All Zanubrutinib pool | 3.8 % | · p.121 |
| Infections (All Grades) in All Zanubrutinib pool | 73.7 % | · p.121 |
| Infections (≥Grade 3) in All Zanubrutinib pool | 27.3 % | · p.121 |
| Neutropenia (All Grades) in MZL patients | 17.0 % | Studies 214+AU003 · p.121 |
| Percentage of Asian patients with >=Grade 3 TEAEs | 66.3 % | · p.105 |
| Percentage of white patients with >=Grade 3 TEAEs | 64.8 % | · p.105 |
| Infections (All Grades) in MZL patients | 52.3 % | Studies 214+AU003 · p.121 |
| Haemorrhage (All Grades) in All Zanubrutinib pool | 54.3 % | · p.121 |
| Infections (≥Grade 3) in MZL patients | 17.0 % | Studies 214+AU003 · p.121 |
| Neutropenia (All Grades) in All Zanubrutinib pool | 34.5 % | · p.121 |
Source: BeOne Medicines Ltd. ↗ · License: EMA - reuse permitted with acknowledgement. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Oncology library →