# Chronic lymphocytic leukaemia

The EU has approved 23 indications of 8 drugs in chronic lymphocytic leukaemia. 2 of them need a biomarker result: TP53/del(17p) (2).

## Approved indications

### TP53/del(17p) mutation

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Idelalisib](https://oncolabels.com/drugs/idelalisib) (Zydelig) | 17p deletion or TP53 mutation | + rituximab | 1st line | Not eligible for any other therapies |
| [Venetoclax](https://oncolabels.com/drugs/venetoclax) (Venclyxto) | 17p deletion or TP53 mutation | Monotherapy | Any line | After unsuitable for or have failed a B-cell receptor pathway inhibitor |

### 17p/TP53 negative

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Venetoclax](https://oncolabels.com/drugs/venetoclax) (Venclyxto) | Absence of 17p deletion or TP53 mutation | Monotherapy | 3rd line+ | Failed both chemoimmunotherapy and a B-cell receptor pathway inhibitor |

### No biomarker required

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Acalabrutinib](https://oncolabels.com/drugs/acalabrutinib) (Calquence) | None | + obinutuzumab | 1st line | - |
| [Acalabrutinib](https://oncolabels.com/drugs/acalabrutinib) (Calquence) | None | + venetoclax with or without obinutuzumab | 1st line | - |
| [Acalabrutinib](https://oncolabels.com/drugs/acalabrutinib) (Calquence) | None | Monotherapy | 1st line | - |
| [Ibrutinib](https://oncolabels.com/drugs/ibrutinib) (Imbruvica) | None | + obinutuzumab | 1st line | - |
| [Ibrutinib](https://oncolabels.com/drugs/ibrutinib) (Imbruvica) | None | + rituximab | 1st line | - |
| [Ibrutinib](https://oncolabels.com/drugs/ibrutinib) (Imbruvica) | None | + venetoclax | 1st line | - |
| [Ibrutinib](https://oncolabels.com/drugs/ibrutinib) (Imbruvica) | None | Monotherapy | 1st line | - |
| [Obinutuzumab](https://oncolabels.com/drugs/obinutuzumab) (Gazyvaro) | None | + chlorambucil | 1st line | Comorbidities making them unsuitable for full-dose fludarabine based therapy |
| [Rituximab](https://oncolabels.com/drugs/rituximab) (MabThera) | None | + chemotherapy | 1st line | - |
| [Venetoclax](https://oncolabels.com/drugs/venetoclax) (Venclyxto) | None | + acalabrutinib with or without obinutuzumab | 1st line | - |
| [Venetoclax](https://oncolabels.com/drugs/venetoclax) (Venclyxto) | None | + ibrutinib | 1st line | - |
| [Venetoclax](https://oncolabels.com/drugs/venetoclax) (Venclyxto) | None | + obinutuzumab | 1st line | - |
| [Acalabrutinib](https://oncolabels.com/drugs/acalabrutinib) (Calquence) | None | Monotherapy | 2nd line | After at least one prior therapy |
| [Ibrutinib](https://oncolabels.com/drugs/ibrutinib) (Imbruvica) | None | + bendamustine and rituximab (BR) | 2nd line | After at least one prior therapy |
| [Ibrutinib](https://oncolabels.com/drugs/ibrutinib) (Imbruvica) | None | Monotherapy | 2nd line | After at least one prior therapy |
| [Idelalisib](https://oncolabels.com/drugs/idelalisib) (Zydelig) | None | + rituximab | 2nd line | After at least one prior therapy |
| [Rituximab](https://oncolabels.com/drugs/rituximab) (MabThera) | None | + chemotherapy | 2nd line | Relapsed or refractory CLL |
| [Venetoclax](https://oncolabels.com/drugs/venetoclax) (Venclyxto) | None | + rituximab | 2nd line | After at least one prior therapy |
| [Pirtobrutinib](https://oncolabels.com/drugs/pirtobrutinib) (Jaypirca) | None | Monotherapy | Any line | - |
| [Zanubrutinib](https://oncolabels.com/drugs/zanubrutinib) (Brukinsa) | None | Monotherapy | Any line | - |

## Label wording

- **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)
- **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)
- **Acalabrutinib** (Calquence), Chronic lymphocytic leukaemia, 1st line: “Calquence as monotherapy or in combination with obinutuzumab is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/calquence-epar-product-information_en.pdf)
- **Acalabrutinib** (Calquence), Chronic lymphocytic leukaemia, 1st line: “Calquence as monotherapy or in combination with obinutuzumab is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/calquence-epar-product-information_en.pdf)
- **Acalabrutinib** (Calquence), Chronic lymphocytic leukaemia, 1st line: “Calquence in combination with venetoclax with or without obinutuzumab is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/calquence-epar-product-information_en.pdf)
- **Acalabrutinib** (Calquence), Chronic lymphocytic leukaemia, 2nd line: “Calquence as monotherapy is indicated for the treatment of adult patients with chronic lymphocytic leukaemia (CLL) who have received at least one prior therapy.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/calquence-epar-product-information_en.pdf)
- **Rituximab** (MabThera), Chronic lymphocytic leukaemia, 1st line: “MabThera in combination with chemotherapy is indicated for the treatment of adult patients with previously untreated and relapsed/refractory CLL.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/mabthera-epar-product-information_en.pdf)
- **Rituximab** (MabThera), Chronic lymphocytic leukaemia, 2nd line: “MabThera in combination with chemotherapy is indicated for the treatment of adult patients with previously untreated and relapsed/refractory CLL.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/mabthera-epar-product-information_en.pdf)
- **Pirtobrutinib** (Jaypirca), Chronic lymphocytic leukaemia, any line: “Jaypirca as monotherapy is indicated for the treatment of adult patients with chronic lymphocytic leukaemia (CLL).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/jaypirca-epar-product-information_en.pdf)
- **Venetoclax** (Venclyxto), Chronic lymphocytic leukaemia, 1st line: “Venclyxto is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL):
• in combination with acalabrutinib with or without obinutuzumab” [SmPC](https://www.ema.europa.eu/en/documents/product-information/venclyxto-epar-product-information_en.pdf)
- **Venetoclax** (Venclyxto), Chronic lymphocytic leukaemia, 1st line: “Venclyxto is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL):
• in combination with acalabrutinib with or without obinutuzumab
• in combination with obinutuzumab (see section 5.1)” [SmPC](https://www.ema.europa.eu/en/documents/product-information/venclyxto-epar-product-information_en.pdf)
- **Venetoclax** (Venclyxto), Chronic lymphocytic leukaemia, 1st line: “Venclyxto is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL):
• in combination with acalabrutinib with or without obinutuzumab
• in combination with obinutuzumab (see section 5.1)
• in combination with ibrutinib” [SmPC](https://www.ema.europa.eu/en/documents/product-information/venclyxto-epar-product-information_en.pdf)
- **Venetoclax** (Venclyxto), Chronic lymphocytic leukaemia, 2nd line: “Venclyxto in combination with rituximab 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/venclyxto-epar-product-information_en.pdf)
- **Venetoclax** (Venclyxto), Chronic lymphocytic leukaemia, any line: “Venclyxto monotherapy is indicated for the treatment of CLL:
• in the presence of 17p deletion or TP53 mutation in adult patients who are unsuitable for or have failed a B-cell receptor pathway inhibitor, or” [SmPC](https://www.ema.europa.eu/en/documents/product-information/venclyxto-epar-product-information_en.pdf)
- **Venetoclax** (Venclyxto), Chronic lymphocytic leukaemia, 3rd line+: “Venclyxto monotherapy is indicated for the treatment of CLL:
• in the presence of 17p deletion or TP53 mutation in adult patients who are unsuitable for or have failed a B-cell receptor pathway inhibitor, or
• in the absence of 17p deletion or TP53 mutation in adult patients who have failed both chemoimmunotherapy and a B-cell receptor pathway inhibitor.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/venclyxto-epar-product-information_en.pdf)
- **Obinutuzumab** (Gazyvaro), Chronic lymphocytic leukaemia, 1st line: “Gazyvaro in combination with chlorambucil is indicated for the treatment of adult patients with previously untreated CLL and with comorbidities making them unsuitable for full-dose fludarabine based therapy (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/gazyvaro-epar-product-information_en.pdf)
- **Idelalisib** (Zydelig), Chronic lymphocytic leukaemia, 2nd line: “Zydelig is indicated in combination with rituximab for the treatment of adult patients with chronic lymphocytic leukaemia (CLL):
• who have received at least one prior therapy (see section 4.4), or
• as first line treatment in the presence of 17p deletion or TP53 mutation in patients who are not eligible for any other therapies (see section 4.4).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/zydelig-epar-product-information_en.pdf)
- **Idelalisib** (Zydelig), Chronic lymphocytic leukaemia, 1st line: “Zydelig is indicated in combination with rituximab for the treatment of adult patients with chronic lymphocytic leukaemia (CLL):
• who have received at least one prior therapy (see section 4.4), or
• as first line treatment in the presence of 17p deletion or TP53 mutation in patients who are not eligible for any other therapies (see section 4.4).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/zydelig-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/chronic-lymphocytic-leukaemia