# Large B-cell lymphoma

The EU has approved 15 indications of 10 drugs in large B-cell lymphoma. 2 of them need a biomarker result: CD20 (2).

## Approved indications

### CD20-positive

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Rituximab](https://oncolabels.com/drugs/rituximab) (MabThera) | CD20-positive | + chemotherapy | 1st line, advanced | DLBCL only; Children and adolescents only; Aged 6 months to less than 18 years old |
| [Rituximab](https://oncolabels.com/drugs/rituximab) (MabThera) | CD20-positive | + CHOP (cyclophosphamide, doxorubicin, vincristine, prednisolone) | Any line | DLBCL only |

### No biomarker required

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Polatuzumab vedotin](https://oncolabels.com/drugs/polatuzumab-vedotin) (Polivy) | None | + rituximab, cyclophosphamide, doxorubicin, and prednisone | 1st line | DLBCL only |
| [Axicabtagene ciloleucel](https://oncolabels.com/drugs/axicabtagene-ciloleucel) (Yescarta) | None | Monotherapy | 2nd line | DLBCL or HGBL only; First-line chemoimmunotherapy (relapsed within 12 months from completion or refractory) |
| [Glofitamab](https://oncolabels.com/drugs/glofitamab) (Columvi) | None | + gemcitabine and oxaliplatin | 2nd line | DLBCL NOS only; Ineligible for autologous stem cell transplant (ASCT) |
| [Lisocabtagene maraleucel](https://oncolabels.com/drugs/lisocabtagene-maraleucel) (Breyanzi) | None | Monotherapy | 2nd line | DLBCL, HGBL or PMBCL only; Relapsed within 12 months from completion of, or refractory to, first-line chemoimmunotherapy |
| [Polatuzumab vedotin](https://oncolabels.com/drugs/polatuzumab-vedotin) (Polivy) | None | + bendamustine and rituximab | 2nd line | DLBCL only; Not candidates for haematopoietic stem cell transplant |
| [Tafasitamab](https://oncolabels.com/drugs/tafasitamab) (Minjuvi) | None | + lenalidomide followed by monotherapy | 2nd line | DLBCL only; Not eligible for autologous stem cell transplant (ASCT) |
| [Axicabtagene ciloleucel](https://oncolabels.com/drugs/axicabtagene-ciloleucel) (Yescarta) | None | Monotherapy | 3rd line+ | DLBCL or PMBCL only; After two or more lines of systemic therapy |
| [Epcoritamab](https://oncolabels.com/drugs/epcoritamab) (Tepkinly) | None | Monotherapy | 3rd line+ | DLBCL only; After two or more lines of systemic therapy |
| [Glofitamab](https://oncolabels.com/drugs/glofitamab) (Columvi) | None | Monotherapy | 3rd line+ | DLBCL only; After two or more lines of systemic therapy |
| [Lisocabtagene maraleucel](https://oncolabels.com/drugs/lisocabtagene-maraleucel) (Breyanzi) | None | Monotherapy | 3rd line+ | DLBCL or PMBCL only; After two or more lines of systemic therapy |
| [Loncastuximab tesirine](https://oncolabels.com/drugs/loncastuximab-tesirine) (Zynlonta) | None | Monotherapy | 3rd line+ | DLBCL or HGBL only; After two or more lines of systemic therapy; Relapsed or refractory |
| [Odronextamab](https://oncolabels.com/drugs/odronextamab) (Ordspono) | None | Monotherapy | 3rd line+ | DLBCL only; After two or more lines of systemic therapy |
| [Tisagenlecleucel](https://oncolabels.com/drugs/tisagenlecleucel) (Kymriah) | None | Monotherapy | 3rd line+ | DLBCL only; After two or more lines of systemic therapy |

## Label wording

- **Polatuzumab vedotin** (Polivy), Large B-cell lymphoma, 1st line: “Polivy in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (R-CHP) is indicated for the treatment of adult patients with previously untreated diffuse large B-cell lymphoma (DLBCL).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/polivy-epar-product-information_en.pdf)
- **Polatuzumab vedotin** (Polivy), Large B-cell lymphoma, 2nd line: “Polivy in combination with bendamustine and rituximab is indicated for the treatment of adult patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) who are not candidates for haematopoietic stem cell transplant.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/polivy-epar-product-information_en.pdf)
- **Glofitamab** (Columvi), Large B-cell lymphoma, 2nd line: “Columvi in combination with gemcitabine and oxaliplatin is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma not otherwise specified (DLBCL NOS) who are ineligible for autologous stem cell transplant (ASCT).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/columvi-epar-product-information_en.pdf)
- **Glofitamab** (Columvi), Large B-cell lymphoma, 3rd line+: “Columvi as monotherapy is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), after two or more lines of systemic therapy.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/columvi-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)
- **Odronextamab** (Ordspono), Large B-cell lymphoma, 3rd line+: “Ordspono as monotherapy is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL) after two or more lines of systemic therapy.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/ordspono-epar-product-information_en.pdf)
- **Loncastuximab tesirine** (Zynlonta), Large B-cell lymphoma, 3rd line+: “Zynlonta as monotherapy is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma (HGBL), after two or more lines of systemic therapy.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/zynlonta-epar-product-information_en.pdf)
- **Tisagenlecleucel** (Kymriah), Large B-cell lymphoma, 3rd line+: “Adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/kymriah-epar-product-information_en.pdf)
- **Lisocabtagene maraleucel** (Breyanzi), Large B-cell lymphoma, 2nd line: “Breyanzi is indicated for the treatment of adult patients with diffuse large B-cell lymphoma (DLBCL), high grade B-cell lymphoma (HGBCL), primary mediastinal large B-cell lymphoma (PMBCL) and follicular lymphoma grade 3B (FL3B), who relapsed within 12 months from completion of, or are refractory to, first-line chemoimmunotherapy.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/breyanzi-epar-product-information_en.pdf)
- **Lisocabtagene maraleucel** (Breyanzi), Large B-cell lymphoma, 3rd line+: “Breyanzi is indicated for the treatment of adult patients with relapsed or refractory DLBCL, PMBCL and FL3B, after two or more lines of systemic therapy.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/breyanzi-epar-product-information_en.pdf)
- **Epcoritamab** (Tepkinly), Large B-cell lymphoma, 3rd line+: “Tepkinly as monotherapy is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/tepkinly-epar-product-information_en.pdf)
- **Axicabtagene ciloleucel** (Yescarta), Large B-cell lymphoma, 2nd line: “Yescarta is indicated for the treatment of adult patients with diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma (HGBL) that relapses within 12 months from completion of, or is refractory to, first-line chemoimmunotherapy.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/yescarta-epar-product-information_en.pdf)
- **Axicabtagene ciloleucel** (Yescarta), Large B-cell lymphoma, 3rd line+: “Yescarta is indicated for the treatment of adult patients with relapsed or refractory (r/r) DLBCL and primary mediastinal large B-cell lymphoma (PMBCL), after two or more lines of systemic therapy.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/yescarta-epar-product-information_en.pdf)
- **Tafasitamab** (Minjuvi), Large B-cell lymphoma, 2nd line: “MINJUVI is indicated in combination with lenalidomide followed by MINJUVI monotherapy for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplant (ASCT).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/minjuvi-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/tumours/large-b-cell-lymphoma