# Ibrutinib

Ibrutinib (Imbruvica, Janssen-Cilag International NV) has 11 EU-approved indications in 3 tumour types.

## Approved indications

### Chronic lymphocytic leukaemia

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| None | + obinutuzumab | 1st line | - |
| None | + rituximab | 1st line | - |
| None | + venetoclax | 1st line | - |
| None | Monotherapy | 1st line | - |
| None | + bendamustine and rituximab (BR) | 2nd line | After at least one prior therapy |
| None | Monotherapy | 2nd line | After at least one prior therapy |

### Mantle cell lymphoma

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| 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) |
| None | Monotherapy | 2nd line | - |

### 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 |
| None | + rituximab | Any line | - |

## Products

### Imbruvica

- Company: Janssen-Cilag International NV
- Target: BTK inhibitor
- Class: Bruton's tyrosine kinase (BTK) inhibitors
- ATC: L01EL01
- EU approval: 21 Oct 2014
- Label revised: 7 Oct 2026
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/imbruvica-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/imbruvica-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/imbruvica

Mechanism (SmPC section 5.1): Covalently binds to the active site of Bruton's tyrosine kinase (BTK) to sustain enzymatic inhibition, blocking B-cell receptor signalling and inhibiting malignant B-cell proliferation and survival.

## 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)
- **Ibrutinib** (Imbruvica), Chronic lymphocytic leukaemia, 1st line: “IMBRUVICA as a single agent or in combination with rituximab or obinutuzumab or venetoclax is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL) (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/imbruvica-epar-product-information_en.pdf)
- **Ibrutinib** (Imbruvica), Chronic lymphocytic leukaemia, 1st line: “IMBRUVICA as a single agent or in combination with rituximab or obinutuzumab or venetoclax is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL) (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/imbruvica-epar-product-information_en.pdf)
- **Ibrutinib** (Imbruvica), Chronic lymphocytic leukaemia, 1st line: “IMBRUVICA as a single agent or in combination with rituximab or obinutuzumab or venetoclax is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL) (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/imbruvica-epar-product-information_en.pdf)
- **Ibrutinib** (Imbruvica), Chronic lymphocytic leukaemia, 1st line: “IMBRUVICA as a single agent or in combination with rituximab or obinutuzumab or venetoclax is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL) (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/imbruvica-epar-product-information_en.pdf)
- **Ibrutinib** (Imbruvica), Chronic lymphocytic leukaemia, 2nd line: “IMBRUVICA as a single agent or in combination with bendamustine and rituximab (BR) is indicated for the treatment of adult patients with CLL who have received at least one prior therapy.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/imbruvica-epar-product-information_en.pdf)
- **Ibrutinib** (Imbruvica), Chronic lymphocytic leukaemia, 2nd line: “IMBRUVICA as a single agent or in combination with bendamustine and rituximab (BR) is indicated for the treatment of adult patients with CLL who have received at least one prior therapy.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/imbruvica-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/drugs/ibrutinib