# Mantle cell lymphoma

The EU has approved 10 indications of 8 drugs in mantle cell lymphoma. None of them needs a biomarker result.

## Approved indications

### No biomarker required

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Acalabrutinib](https://oncolabels.com/drugs/acalabrutinib) (Calquence) | None | + bendamustine and rituximab | 1st line | Not eligible for autologous stem cell transplant (ASCT) |
| [Bortezomib](https://oncolabels.com/drugs/bortezomib) (Velcade) | None | + rituximab, cyclophosphamide, doxorubicin and prednisone | 1st line | Unsuitable for haematopoietic stem cell transplantation |
| [Ibrutinib](https://oncolabels.com/drugs/ibrutinib) (Imbruvica) | None | + rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisolone (IMBRUVICA + R-CHOP) alternating with R-DHAP (or R-DHAOx) without IMBRUVICA, followed by IMBRUVICA monotherapy | 1st line | Eligible for autologous stem cell transplantation (ASCT) |
| [Acalabrutinib](https://oncolabels.com/drugs/acalabrutinib) (Calquence) | None | Monotherapy | 2nd line | No prior BTK inhibitor |
| [Ibrutinib](https://oncolabels.com/drugs/ibrutinib) (Imbruvica) | None | Monotherapy | 2nd line | - |
| [Lenalidomide](https://oncolabels.com/drugs/lenalidomide) (Revlimid) | None | Monotherapy | 2nd line | Relapsed or refractory |
| [Pirtobrutinib](https://oncolabels.com/drugs/pirtobrutinib) (Jaypirca) | None | Monotherapy | 2nd line | Previously treated with a Bruton’s tyrosine kinase (BTK) inhibitor |
| [Temsirolimus](https://oncolabels.com/drugs/temsirolimus) (Torisel) | None | Monotherapy | 2nd line | Relapsed and/or refractory |
| [Brexucabtagene autoleucel](https://oncolabels.com/drugs/brexucabtagene-autoleucel) (Tecartus) | None | Monotherapy | 3rd line+ | After two or more lines of systemic therapy including a BTK inhibitor |
| [Lisocabtagene maraleucel](https://oncolabels.com/drugs/lisocabtagene-maraleucel) (Breyanzi) | None | Monotherapy | 3rd line+ | After at least two lines of systemic therapy including a Bruton’s tyrosine kinase (BTK) inhibitor |

## Label wording

- **Ibrutinib** (Imbruvica), Mantle cell lymphoma, 1st line: “IMBRUVICA in combination with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisolone (IMBRUVICA + R-CHOP) alternating with R-DHAP (or R-DHAOx) without IMBRUVICA, followed by IMBRUVICA monotherapy, is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL) who would be eligible for autologous stem cell transplantation (ASCT).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/imbruvica-epar-product-information_en.pdf)
- **Ibrutinib** (Imbruvica), Mantle cell lymphoma, 2nd line: “IMBRUVICA as a single agent is indicated for the treatment of adult patients with relapsed or refractory MCL.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/imbruvica-epar-product-information_en.pdf)
- **Acalabrutinib** (Calquence), Mantle cell lymphoma, 1st line: “Calquence in combination with bendamustine and rituximab (BR) is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL) who are not eligible for autologous stem cell transplant (ASCT).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/calquence-epar-product-information_en.pdf)
- **Acalabrutinib** (Calquence), Mantle cell lymphoma, 2nd line: “Calquence as monotherapy is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) not previously treated with a BTK inhibitor.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/calquence-epar-product-information_en.pdf)
- **Pirtobrutinib** (Jaypirca), Mantle cell lymphoma, 2nd line: “Jaypirca as monotherapy is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) who have been previously treated with a Bruton’s tyrosine kinase (BTK) inhibitor.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/jaypirca-epar-product-information_en.pdf)
- **Lisocabtagene maraleucel** (Breyanzi), Mantle cell lymphoma, 3rd line+: “Breyanzi is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy including a Bruton’s tyrosine kinase (BTK) inhibitor.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/breyanzi-epar-product-information_en.pdf)
- **Lenalidomide** (Revlimid), Mantle cell lymphoma, 2nd line: “Revlimid as monotherapy is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (see sections 4.4 and 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/revlimid-epar-product-information_en.pdf)
- **Brexucabtagene autoleucel** (Tecartus), Mantle cell lymphoma, 3rd line+: “Tecartus is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) after two or more lines of systemic therapy including a Bruton’s tyrosine kinase (BTK) inhibitor.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/tecartus-epar-product-information_en.pdf)
- **Bortezomib** (Velcade), Mantle cell lymphoma, 1st line: “VELCADE in combination with rituximab, cyclophosphamide, doxorubicin and prednisone is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma who are unsuitable for haematopoietic stem cell transplantation.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/velcade-epar-product-information_en.pdf)
- **Temsirolimus** (Torisel), Mantle cell lymphoma, 2nd line: “Torisel is indicated for the treatment of adult patients with relapsed and/or refractory mantle cell lymphoma (MCL) (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/torisel-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/mantle-cell-lymphoma