# Zanubrutinib

Zanubrutinib (Brukinsa, BeOne Medicines Netherlands B. V.) has 5 EU-approved indications in 4 tumour types.

## Approved indications

### Chronic lymphocytic leukaemia

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| None | Monotherapy | Any line | - |

### Follicular lymphoma

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| None | + obinutuzumab | 3rd line+ | After at least two prior systemic therapies; Relapsed or refractory |

### Marginal zone lymphoma

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| None | Monotherapy | 2nd line | After at least one prior anti-CD20-based therapy |

### Waldenström macroglobulinaemia

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| None | Monotherapy | 1st line | Unsuitable for chemo-immunotherapy |
| None | Monotherapy | 2nd line | After at least one prior therapy |

## Products

### Brukinsa

- Company: BeOne Medicines Netherlands B. V.
- Target: BTK inhibitor
- Class: Bruton's tyrosine kinase (BTK) inhibitors
- ATC: L01EL03
- EU approval: 22 Nov 2021
- Label revised: 4 Nov 2026
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/brukinsa-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/brukinsa-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/brukinsa

Mechanism (SmPC section 5.1): Zanubrutinib covalently binds and inhibits Bruton's tyrosine kinase, blocking B-cell receptor signalling pathways essential for B-cell proliferation, trafficking, and chemotaxis.

## 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)
- **Zanubrutinib** (Brukinsa), Marginal zone lymphoma, 2nd line: “BRUKINSA as monotherapy is indicated for the treatment of adult patients with marginal zone lymphoma (MZL) who have received at least one prior anti-CD20-based therapy.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/brukinsa-epar-product-information_en.pdf)
- **Zanubrutinib** (Brukinsa), Chronic lymphocytic leukaemia, any line: “BRUKINSA as monotherapy is indicated for the treatment of adult patients with chronic lymphocytic leukemia (CLL).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/brukinsa-epar-product-information_en.pdf)
- **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)

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/drugs/zanubrutinib