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 the regulatory assessment of a Type II variation for Brukinsa (zanubrutinib) to include adult patients with chronic lymphocytic leukaemia (CLL) or small lymphocytic leukaemia (SLL). Based on two Phase 3 studies (BGB-3111-304 and BGB-3111-305), the application demonstrated zanubrutinib's efficacy and safety. Pharmacokinetic and pharmacodynamic analyses found no apparent exposure-response relationship for efficacy (PFS or ORR) or safety. Clinical pharmacology supported the 320 mg daily dose. Study BGB-3111-304 showed superior progression-free survival (PFS) for zanubrutinib compared to bendamustine + rituximab in previously untreated CLL/SLL. Study BGB-3111-305 demonstrated non-inferiority and superiority in overall response rate against ibrutinib in relapsed/refractory CLL/SLL. Zanubrutinib exhibited a favorable safety profile with lower adverse event rates compared to comparators. The CHMP recommended approval for this extended indication.
Key findings — cited to the page
| Non-melanoma skin cancer (All grades) | 7.4 % | · p.178 |
| Neutropenia (Grade 3+) | 18.5 % | · p.178 |
| Pneumonia (Grade 3+) | 7.0 % | · p.178 |
| Haemorrhage (All grades) | 48.1 % | · p.178 |
| Diarrhoea (Grade 3+) | 1.5 % | · p.178 |
| Diarrhoea (All grades) | 18.8 % | · p.178 |
| Infections by SOC (All grades) | 65.7 % | · p.178 |
| Pneumonia (All grades) | 21.8 % | · p.178 |
| Neutropenia (All grades) | 27.5 % | · p.178 |
| OS significance level (final OS analysis) | 0.0249 | BGB-3111-304 · p.61 |
| PFS significance level (1-sided) | 0.025 | BGB-3111-304 · p.61 |
| OS significance level (interim/final PFS analysis) | 0.00005 | BGB-3111-304 · p.61 |
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 →