Roche Holding AG — MabThera EMA EPAR variation assessment report (EMEA/H/C/000165, 1998)
Roche Holding AG · 1998 · EMA EPAR variation assessment report · company profile →
Report summary
This report summarizes Roche's Type II variation application for MabThera (rituximab) to treat pediatric patients (6 months to <18 years) with previously untreated advanced diffuse large B-cell lymphoma, Burkitt lymphoma/leukaemia, or Burkitt-like lymphoma, in combination with chemotherapy. The application, supported by a completed Paediatric Investigation Plan, includes updates to product information. Pharmacokinetic studies demonstrated comparable rituximab parameters between pediatric age groups and adults, supporting a body surface area-based dosing strategy. The safety profile in pediatric oncology patients was consistent with adults. Efficacy data showed significant improvements in event-free and overall survival. The CHMP recommended approval for this pediatric indication extension.
Key findings — cited to the page
| Rituximab elimination half-life (median) | 25.7 days | Study BO25380 · p.16 |
| Number of pediatric subjects in PK sub-study | 35 subjects | Study BO25380 · p.27 |
| Number of patients in PK set (age group >=3 to <12 years) | 26 patients | Study BO25380 · p.15 |
| Number of patients in PK set (age group >=12 to <18 years) | 9 patients | Study BO25380 · p.15 |
| Rituximab elimination half-life (median) in adult NHL | 22 days | · p.16 |
| Proposed rituximab dose for pediatric patients | 375 mg/m² | EU · p.27 |
| Number of patients in PK set | 35 patients | Study BO25380 · p.15 |
| Type II variation submission date | 5 June 2019 | MabThera · p.5 |
| CHMP opinion adoption date | 30 January 2020 | MabThera · p.6 |
| Study BO25380 phase | Phase III | Study BO25380 (Inter-B-NHL Ritux 2010) · p.11 |
| Study BO25380 age range | 6 months to less than 18 years years | Study BO25380 (Inter-B-NHL Ritux 2010) · p.11 |
| Rituximab elimination half-life | 25.7 days | · p.28 |
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 →