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 summarizes a Type II variation application for Brukinsa (zanubrutinib) with obinutuzumab for relapsed/refractory follicular lymphoma (FL) patients after two prior treatments, addressing an unmet medical need. Based on studies BGB-3111-212 and BGB-3111-GA101-001, the combination demonstrated superior overall response rates and progression-free survival compared to obinutuzumab monotherapy. Zanubrutinib's pharmacokinetics are consistent and unaffected by obinutuzumab, with no significant exposure-response relationships found. While the combination showed improved efficacy, it also led to higher rates of infections and thrombocytopenia. Uncertainties remain regarding long-term duration of response and overall survival due to data immaturity. Ongoing pharmacovigilance will monitor the long-term safety profile.
Key findings — cited to the page
| Neutropenia (Grades 3 to 4) | 50% | · p.11 |
| Blood & lymphatic system disorders (>= Grade 3) | 19.7 % | BGB-3111-212 (Obinutuzumab) · p.130 |
| Infections & Infestations (>= Grade 3) | 14.1 % | BGB-3111-212 (Obinutuzumab) · p.130 |
| Grade 3 AE | 65.7 % | BGB-3111-212 (Zanubrutinib + obinutuzumab) · p.130 |
| Blood & lymphatic system disorders (>= Grade 3) | 23.1 % | BGB-3111-212 (Zanubrutinib + obinutuzumab) · p.130 |
| Blood & lymphatic system disorders (>= Grade 3) | 33 patients | BGB-3111-212 (Zanubrutinib + obinutuzumab) · p.130 |
| Grade 3 AE | 94 patients | BGB-3111-212 (Zanubrutinib + obinutuzumab) · p.130 |
| Blood & lymphatic system disorders (>= Grade 3) | 14 patients | BGB-3111-212 (Obinutuzumab) · p.130 |
| Infections & Infestations (>= Grade 3) | 45 patients | BGB-3111-212 (Zanubrutinib + obinutuzumab) · p.130 |
| Infections & Infestations (>= Grade 3) | 31.5 % | BGB-3111-212 (Zanubrutinib + obinutuzumab) · p.130 |
| Infections & Infestations (>= Grade 3) | 10 patients | BGB-3111-212 (Obinutuzumab) · p.130 |
| Grade 3 AE | 47.9 % | BGB-3111-212 (Obinutuzumab) · p.130 |
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 →