Mantle cell lymphoma

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

Line of therapy

Approved indications, Mantle cell lymphoma
DrugBiomarker requirementRegimenSettingConditions
No biomarker required10
Acalabrutinib
Calquence
None
+ bendamustine and rituximab
1L
Not eligible for autologous stem cell transplant (ASCT)
Bortezomib
Velcade
None
+ rituximab, cyclophosphamide, doxorubicin and prednisone
1L
Unsuitable for haematopoietic stem cell transplantation
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
1L
Eligible for autologous stem cell transplantation (ASCT)
Acalabrutinib
Calquence
None
Monotherapy
2L
No prior BTK inhibitor
Ibrutinib
Imbruvica
None
Monotherapy
2L
None
Lenalidomide
Revlimid
None
Monotherapy
2L
Relapsed or refractory
Pirtobrutinib
Jaypircaconditional
None
Monotherapy
2L
Previously treated with a Bruton’s tyrosine kinase (BTK) inhibitor
None
Monotherapy
2L
Relapsed and/or refractory
Brexucabtagene autoleucel
Tecartusconditional
None
Monotherapy
3L+
After two or more lines of systemic therapy including a BTK inhibitor
None
Monotherapy
3L+
After at least two lines of systemic therapy including a Bruton’s tyrosine kinase (BTK) inhibitor
Label wording10

The sentence from section 4.1 of the SmPC that each indication above comes from.

  1. Ibrutinib (Imbruvica)
    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).
  2. Ibrutinib (Imbruvica)
    IMBRUVICA as a single agent is indicated for the treatment of adult patients with relapsed or refractory MCL.
  3. Acalabrutinib (Calquence)
    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).
  4. Acalabrutinib (Calquence)
    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.
  5. Pirtobrutinib (Jaypirca)
    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.
  6. Lisocabtagene maraleucel (Breyanzi)
    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.
  7. Lenalidomide (Revlimid)
    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).
  8. Brexucabtagene autoleucel (Tecartus)
    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.
  9. Bortezomib (Velcade)
    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.
  10. Temsirolimus (Torisel)
    Torisel is indicated for the treatment of adult patients with relapsed and/or refractory mantle cell lymphoma (MCL) (see section 5.1).