Roche Holding AG — Avastin EMA EPAR variation assessment report (EMEA/H/C/000582, 2005)
Roche Holding AG · 2005 · EMA EPAR variation assessment report · company profile →
Report summary
This report summarizes a Type II variation assessment for Roche's Avastin (bevacizumab) to incorporate paediatric study results into its SmPC and PIL. The HERBY (BO25041) study, investigating bevacizumab in newly diagnosed high-grade glioma in children, failed to meet its primary endpoint of improved event-free survival when added to chemoradiation. Despite this, no new safety concerns were raised, and the overall benefit-risk profile for Avastin's approved indications remains favorable.
Key findings — cited to the page
| Grade ≥ 3 AESIs and SAEs incidence | higher | BO25041 · p.11 |
| Grade ≥ 3 AEs incidence | similar | BO25041 · p.11 |
| Grade 3 AEs in Young Patient Cohort | 2 | Young Patient Cohort · p.12 |
| Median Overall Survival (OS) in RT/T arm | 27 months | BO25041 · p.9 |
| Event-Free Survival (EFS) 95% CI | 0.90, 2.30 | BO25041 · p.12 |
| AEs leading to withdrawal incidence | higher | BO25041 · p.11 |
| Event-Free Survival (EFS) Hazard Ratio | 1.44 | BO25041 · p.12 |
| CRRC-assessed time to EFS for Young Patient Cohort | 50, 90, 545* days | Young Patient Cohort · p.12 |
| Young Patient Cohort enrollment | 3 patients | Young Patient Cohort · p.12 |
| Median Overall Survival (OS) in Bv + RT/T arm | 18.3 months | BO25041 · p.9 |
| Overall Survival (OS) 95% CI | 0.72, 2.09 | BO25041 · p.9 |
| Overall Survival (OS) Hazard Ratio | 1.23 | BO25041 · p.9 |
Source: Roche Holding AG ↗ · 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 →