MabThera
Oncology· 62 cited findings· 1 source document
Company: Roche Holding AG
What the regulatory reviews say
MabThera (rituximab) is a drug for which a Type II variation was submitted on 5 June 2019, with a CHMP opinion adoption date of 30 January 2020. The proposed rituximab dose for pediatric patients is 375 mg/m². The median rituximab elimination half-life in adult Non-Hodgkin Lymphoma (NHL) patients is 22 days.
In a Phase III study (Study BO25380) involving patients aged 6 months to less than 18 years, the 1-year Event-Free Survival (EFS) rate in the R-LMB arm was 94.2%, compared to 81.5% in the LMB arm. The EFS Hazard Ratio (HR) was 0.33. The 3-year EFS rate in the R-Chemo ITT group was 93.9%, versus 82.3% in the Chemo ITT group, with a 3-year EFS HR of 0.32. Progression/relapse occurred in 30.0% of the R-Chemo group, compared to 75.0% in the Chemo group.
Regarding safety, febrile neutropenia was observed in 92.6% of the treatment arm and 90.8% of the control arm. Infections occurred in 41.4% of the treatment arm and 35.3% of the control arm. Serious Adverse Events (SAE) were reported in 49.5% of the treatment arm and 39.3% of the control arm. There were 77 fatal AEs, with 25% related to infections. Eight deaths occurred in the R-chemo arm.
Key figures — cited to the source page
| 1-year EFS rate (R-LMB arm) | 94.2 % | Roche Holding AG — MabThera EMA EPAR variation assessment re, p.89 |
| 1-year EFS rate (LMB arm) | 81.5 % | Roche Holding AG — MabThera EMA EPAR variation assessment re, p.89 |
| EFS HR | 0.33 | Roche Holding AG — MabThera EMA EPAR variation assessment re, p.89 |
| Febrile neutropenia (Treatment arm) | 92.6 % | Roche Holding AG — MabThera EMA EPAR variation assessment re, p.90 |
| Febrile neutropenia (Control arm) | 90.8 % | Roche Holding AG — MabThera EMA EPAR variation assessment re, p.90 |
| SAE (Treatment arm) | 49.5 % | Roche Holding AG — MabThera EMA EPAR variation assessment re, p.90 |
| SAE (Control arm) | 39.3 % | Roche Holding AG — MabThera EMA EPAR variation assessment re, p.90 |
| CHMP opinion adoption date | 30 January 2020 | Roche Holding AG — MabThera EMA EPAR variation assessment re, p.6 |
Source documents
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Figures are as stated in the cited regulatory review documents (different drugs are studied in different trials — values are not head-to-head comparisons). Educational reference only — not medical or investment advice.