# Follicular lymphoma

The EU has approved 19 indications of 12 drugs in follicular lymphoma. None of them needs a biomarker result.

## Approved indications

### No biomarker required

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Obinutuzumab](https://oncolabels.com/drugs/obinutuzumab) (Gazyvaro) | None | + chemotherapy | 1st line, advanced | Then maintenance monotherapy |
| [Rituximab](https://oncolabels.com/drugs/rituximab) (MabThera) | None | + chemotherapy | 1st line, advanced | - |
| [Obinutuzumab](https://oncolabels.com/drugs/obinutuzumab) (Gazyvaro) | None | Monotherapy | Maintenance, advanced | After Gazyvaro in combination with chemotherapy achieving a response |
| [Obinutuzumab](https://oncolabels.com/drugs/obinutuzumab) (Gazyvaro) | None | Monotherapy | Maintenance | After Gazyvaro in combination with bendamustine without progression; did not respond or progressed during or up to 6 months after treatment with rituximab or a rituximab-containing regimen |
| [Rituximab](https://oncolabels.com/drugs/rituximab) (MabThera) | None | Monotherapy | Maintenance | Responding to induction therapy |
| [Epcoritamab](https://oncolabels.com/drugs/epcoritamab) (Tepkinly) | None | + lenalidomide and rituximab | 2nd line | - |
| [Lenalidomide](https://oncolabels.com/drugs/lenalidomide) (Revlimid) | None | + rituximab | 2nd line | Grade 1–3A only; Previously treated |
| [Lisocabtagene maraleucel](https://oncolabels.com/drugs/lisocabtagene-maraleucel) (Breyanzi) | None | Monotherapy | 2nd line | Grade 3B only; Relapsed within 12 months from completion of, or refractory to, first-line chemoimmunotherapy |
| [Obinutuzumab](https://oncolabels.com/drugs/obinutuzumab) (Gazyvaro) | None | + bendamustine | 2nd line | Then maintenance monotherapy; Did not respond or progressed during or up to 6 months after treatment with rituximab or a rituximab-containing regimen |
| [Rituximab](https://oncolabels.com/drugs/rituximab) (MabThera) | None | Monotherapy | 2nd line, advanced | Chemoresistant or in second or subsequent relapse after chemotherapy |
| [Tafasitamab](https://oncolabels.com/drugs/tafasitamab) (Minjuvi) | None | + lenalidomide and rituximab | 2nd line | After at least one line of systemic therapy; Grade 1-3a |
| [Axicabtagene ciloleucel](https://oncolabels.com/drugs/axicabtagene-ciloleucel) (Yescarta) | None | Monotherapy | 3rd line+ | After three or more lines of systemic therapy |
| [Epcoritamab](https://oncolabels.com/drugs/epcoritamab) (Tepkinly) | None | Monotherapy | 3rd line+ | After two or more lines of systemic therapy |
| [Idelalisib](https://oncolabels.com/drugs/idelalisib) (Zydelig) | None | Monotherapy | 3rd line+ | Refractory to two prior lines of treatment |
| [Lisocabtagene maraleucel](https://oncolabels.com/drugs/lisocabtagene-maraleucel) (Breyanzi) | None | Monotherapy | 3rd line+ | After two or more lines of systemic therapy |
| [Mosunetuzumab](https://oncolabels.com/drugs/mosunetuzumab) (Lunsumio) | None | Monotherapy | 3rd line+ | After at least two prior systemic therapies |
| [Odronextamab](https://oncolabels.com/drugs/odronextamab) (Ordspono) | None | Monotherapy | 3rd line+ | After two or more lines of systemic therapy |
| [Tisagenlecleucel](https://oncolabels.com/drugs/tisagenlecleucel) (Kymriah) | None | Monotherapy | 3rd line+ | After two or more lines of systemic therapy |
| [Zanubrutinib](https://oncolabels.com/drugs/zanubrutinib) (Brukinsa) | None | + obinutuzumab | 3rd line+ | After at least two prior systemic therapies; Relapsed or refractory |

## Label wording

- **Zanubrutinib** (Brukinsa), Follicular lymphoma, 3rd line+: “BRUKINSA in combination with obinutuzumab is indicated for the treatment of adult patients with refractory or relapsed follicular lymphoma (FL) who have received at least two prior systemic therapies.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/brukinsa-epar-product-information_en.pdf)
- **Mosunetuzumab** (Lunsumio), Follicular lymphoma, 3rd line+: “Lunsumio as monotherapy is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) who have received at least two prior systemic therapies.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/lunsumio-epar-product-information_en.pdf)
- **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)
- **Odronextamab** (Ordspono), Follicular lymphoma, 3rd line+: “Ordspono as monotherapy is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (r/r FL) after two or more lines of systemic therapy.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/ordspono-epar-product-information_en.pdf)
- **Tisagenlecleucel** (Kymriah), Follicular lymphoma, 3rd line+: “Adult patients with relapsed or refractory follicular lymphoma (FL) 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), Follicular 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), Follicular 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), Follicular lymphoma, 2nd line: “Tepkinly in combination with lenalidomide and rituximab is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/tepkinly-epar-product-information_en.pdf)
- **Epcoritamab** (Tepkinly), Follicular lymphoma, 3rd line+: “Tepkinly as monotherapy is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/tepkinly-epar-product-information_en.pdf)
- **Lenalidomide** (Revlimid), Follicular lymphoma, 2nd line: “Revlimid in combination with rituximab (anti-CD20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma (Grade 1 – 3a).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/revlimid-epar-product-information_en.pdf)
- **Axicabtagene ciloleucel** (Yescarta), Follicular lymphoma, 3rd line+: “Yescarta is indicated for the treatment of adult patients with r/r follicular lymphoma (FL) after three or more lines of systemic therapy.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/yescarta-epar-product-information_en.pdf)
- **Obinutuzumab** (Gazyvaro), Follicular lymphoma, 1st line, advanced: “Gazyvaro in combination with chemotherapy followed by Gazyvaro maintenance therapy in patients achieving a response, is indicated for the treatment of patients with previously untreated advanced FL (see section 5.1)” [SmPC](https://www.ema.europa.eu/en/documents/product-information/gazyvaro-epar-product-information_en.pdf)
- **Obinutuzumab** (Gazyvaro), Follicular lymphoma, maintenance, advanced: “Gazyvaro in combination with chemotherapy followed by Gazyvaro maintenance therapy in patients achieving a response, is indicated for the treatment of patients with previously untreated advanced FL (see section 5.1)” [SmPC](https://www.ema.europa.eu/en/documents/product-information/gazyvaro-epar-product-information_en.pdf)
- **Obinutuzumab** (Gazyvaro), Follicular lymphoma, 2nd line: “Gazyvaro in combination with bendamustine followed by Gazyvaro maintenance is indicated for the treatment of patients with FL who did not respond or who progressed during or up to 6 months after treatment with rituximab or a rituximab-containing regimen.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/gazyvaro-epar-product-information_en.pdf)
- **Obinutuzumab** (Gazyvaro), Follicular lymphoma, maintenance: “Gazyvaro in combination with bendamustine followed by Gazyvaro maintenance is indicated for the treatment of patients with FL who did not respond or who progressed during or up to 6 months after treatment with rituximab or a rituximab-containing regimen.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/gazyvaro-epar-product-information_en.pdf)
- **Tafasitamab** (Minjuvi), Follicular lymphoma, 2nd line: “MINJUVI is indicated in combination with lenalidomide and rituximab for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) (Grade 1-3a) after at least one line of systemic therapy.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/minjuvi-epar-product-information_en.pdf)
- **Idelalisib** (Zydelig), Follicular lymphoma, 3rd line+: “Zydelig is indicated as monotherapy for the treatment of adult patients with follicular lymphoma (FL) that is refractory to two prior lines of treatment (see section 4.4).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/zydelig-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/follicular-lymphoma