Waldenström macroglobulinaemia

The EU has approved 5 indications of 2 drugs in waldenström macroglobulinaemia. None of them needs a biomarker result.

Line of therapy

Approved indications, Waldenström macroglobulinaemia
DrugBiomarker requirementRegimenSettingConditions
No biomarker required5
Ibrutinib
Imbruvica
None
Monotherapy
1L
Unsuitable for chemo-immunotherapy
Zanubrutinib
Brukinsa
None
Monotherapy
1L
Unsuitable for chemo-immunotherapy
Ibrutinib
Imbruvica
None
Monotherapy
2L
After at least one prior therapy
Zanubrutinib
Brukinsa
None
Monotherapy
2L
After at least one prior therapy
Ibrutinib
Imbruvica
None
+ rituximab
Any line
None
Label wording5

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

  1. Zanubrutinib (Brukinsa)
    BRUKINSA as monotherapy is indicated for the treatment of adult patients with Waldenström’s macroglobulinaemia (WM) who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo-immunotherapy.
  2. Zanubrutinib (Brukinsa)
    BRUKINSA as monotherapy is indicated for the treatment of adult patients with Waldenström’s macroglobulinaemia (WM) who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo-immunotherapy.
  3. Ibrutinib (Imbruvica)
    IMBRUVICA as a single agent is indicated for the treatment of adult patients with Waldenström’s macroglobulinaemia (WM) who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo-immunotherapy.
  4. Ibrutinib (Imbruvica)
    IMBRUVICA as a single agent is indicated for the treatment of adult patients with Waldenström’s macroglobulinaemia (WM) who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo-immunotherapy.
  5. Ibrutinib (Imbruvica)
    IMBRUVICA in combination with rituximab is indicated for the treatment of adult patients with WM.