# Waldenström macroglobulinaemia

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

## Approved indications

### No biomarker required

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Ibrutinib](https://oncolabels.com/drugs/ibrutinib) (Imbruvica) | None | Monotherapy | 1st line | Unsuitable for chemo-immunotherapy |
| [Zanubrutinib](https://oncolabels.com/drugs/zanubrutinib) (Brukinsa) | None | Monotherapy | 1st line | Unsuitable for chemo-immunotherapy |
| [Ibrutinib](https://oncolabels.com/drugs/ibrutinib) (Imbruvica) | None | Monotherapy | 2nd line | After at least one prior therapy |
| [Zanubrutinib](https://oncolabels.com/drugs/zanubrutinib) (Brukinsa) | None | Monotherapy | 2nd line | After at least one prior therapy |
| [Ibrutinib](https://oncolabels.com/drugs/ibrutinib) (Imbruvica) | None | + rituximab | Any line | - |

## Label wording

- **Zanubrutinib** (Brukinsa), Waldenström macroglobulinaemia, 2nd line: “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.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/brukinsa-epar-product-information_en.pdf)
- **Zanubrutinib** (Brukinsa), Waldenström macroglobulinaemia, 1st line: “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.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/brukinsa-epar-product-information_en.pdf)
- **Ibrutinib** (Imbruvica), Waldenström macroglobulinaemia, 1st line: “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.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/imbruvica-epar-product-information_en.pdf)
- **Ibrutinib** (Imbruvica), Waldenström macroglobulinaemia, 2nd line: “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.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/imbruvica-epar-product-information_en.pdf)
- **Ibrutinib** (Imbruvica), Waldenström macroglobulinaemia, any line: “IMBRUVICA in combination with rituximab is indicated for the treatment of adult patients with WM.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/imbruvica-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/waldenstrom-macroglobulinaemia