# Rituximab

Rituximab (MabThera, Roche Registration GmbH) has 8 EU-approved indications in 4 tumour types. 3 need a biomarker result: CD20 (3).

## Approved indications

### Chronic lymphocytic leukaemia

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| None | + chemotherapy | 1st line | - |
| None | + chemotherapy | 2nd line | Relapsed or refractory CLL |

### Large B-cell lymphoma

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| CD20-positive | + chemotherapy | 1st line, advanced | DLBCL only; Children and adolescents only; Aged 6 months to less than 18 years old |
| CD20-positive | + CHOP (cyclophosphamide, doxorubicin, vincristine, prednisolone) | Any line | DLBCL only |

### Follicular lymphoma

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| None | + chemotherapy | 1st line, advanced | - |
| None | Monotherapy | Maintenance | Responding to induction therapy |
| None | Monotherapy | 2nd line, advanced | Chemoresistant or in second or subsequent relapse after chemotherapy |

### Other B-cell lymphoma

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| CD20-positive | + chemotherapy | 1st line, advanced | Children and adolescents only; Aged 6 months to less than 18 years old |

## Products

### MabThera

- Company: Roche Registration GmbH
- Target: Anti-CD20 monoclonal antibody
- Class: CD20 (clusters of differentiation 20) inhibitors
- ATC: L01FA01
- EU approval: 2 Jun 1998
- Label revised: 6 Aug 2026
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/mabthera-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/mabthera-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/mabthera
- Biosimilars and generics: Ruxience, Riximyo, Rixathon, Truxima, Blitzima, Ituxredi

Mechanism (SmPC section 5.1): Binds specifically to CD20 on B lymphocytes, recruiting immune effector functions to mediate B-cell lysis via CDC, ADCC, and induction of apoptosis.

## Label wording

- **Rituximab** (MabThera), Follicular lymphoma, 1st line, advanced: “MabThera is indicated for the treatment of previously untreated adult patients with stage III-IV follicular lymphoma in combination with chemotherapy.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/mabthera-epar-product-information_en.pdf)
- **Rituximab** (MabThera), Follicular lymphoma, maintenance: “MabThera maintenance therapy is indicated for the treatment of adult follicular lymphoma patients responding to induction therapy.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/mabthera-epar-product-information_en.pdf)
- **Rituximab** (MabThera), Follicular lymphoma, 2nd line, advanced: “MabThera monotherapy is indicated for treatment of adult patients with stage III-IV follicular lymphoma who are chemoresistant or are in their second or subsequent relapse after chemotherapy.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/mabthera-epar-product-information_en.pdf)
- **Rituximab** (MabThera), Large B-cell lymphoma, any line: “MabThera is indicated for the treatment of adult patients with CD20 positive diffuse large B-cell non-Hodgkin’s lymphoma in combination with CHOP (cyclophosphamide, doxorubicin, vincristine, prednisolone) chemotherapy.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/mabthera-epar-product-information_en.pdf)
- **Rituximab** (MabThera), Large B-cell lymphoma, 1st line, advanced: “MabThera in combination with chemotherapy is indicated for the treatment of paediatric patients (aged 6 months to less than 18 years old) with previously untreated advanced stage CD20 positive diffuse large B-cell lymphoma (DLBCL), Burkitt lymphoma (BL)/Burkitt leukaemia (mature B-cell acute leukaemia) (BAL) or Burkitt-like lymphoma (BLL).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/mabthera-epar-product-information_en.pdf)
- **Rituximab** (MabThera), Other B-cell lymphoma, 1st line, advanced: “MabThera in combination with chemotherapy is indicated for the treatment of paediatric patients (aged 6 months to less than 18 years old) with previously untreated advanced stage CD20 positive diffuse large B-cell lymphoma (DLBCL), Burkitt lymphoma (BL)/Burkitt leukaemia (mature B-cell acute leukaemia) (BAL) or Burkitt-like lymphoma (BLL).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/mabthera-epar-product-information_en.pdf)
- **Rituximab** (MabThera), Chronic lymphocytic leukaemia, 1st line: “MabThera in combination with chemotherapy is indicated for the treatment of adult patients with previously untreated and relapsed/refractory CLL.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/mabthera-epar-product-information_en.pdf)
- **Rituximab** (MabThera), Chronic lymphocytic leukaemia, 2nd line: “MabThera in combination with chemotherapy is indicated for the treatment of adult patients with previously untreated and relapsed/refractory CLL.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/mabthera-epar-product-information_en.pdf)

Source: section 4.1 of each summary of product characteristics (SmPC), EMA data as of 5 Nov 2026. AI models structured these entries and no person has checked them yet. oncolabels is a non-commercial reference for education and research and gives no medical advice; the current SmPC takes precedence.

Data under CC BY 4.0: credit oncolabels and the European Medicines Agency. Page: https://oncolabels.com/drugs/rituximab