# Venetoclax

Venetoclax (Venclyxto, AbbVie Deutschland GmbH & Co. KG) has 7 EU-approved indications in 2 tumour types. 1 needs a biomarker result: TP53/del(17p) (1).

## Approved indications

### Acute myeloid leukaemia

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| None | + a hypomethylating agent | 1st line | Ineligible for intensive chemotherapy |

### Chronic lymphocytic leukaemia

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| None | + acalabrutinib with or without obinutuzumab | 1st line | - |
| None | + ibrutinib | 1st line | - |
| None | + obinutuzumab | 1st line | - |
| None | + rituximab | 2nd line | After at least one prior therapy |
| Absence of 17p deletion or TP53 mutation | Monotherapy | 3rd line+ | Failed both chemoimmunotherapy and a B-cell receptor pathway inhibitor |
| 17p deletion or TP53 mutation | Monotherapy | Any line | After unsuitable for or have failed a B-cell receptor pathway inhibitor |

## Products

### Venclyxto

- Company: AbbVie Deutschland GmbH & Co. KG
- Target: BCL-2 inhibitor
- Class: Other antineoplastic agents
- ATC: L01XX52
- EU approval: 4 Dec 2016
- Label revised: 8 Jul 2026
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/venclyxto-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/venclyxto-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/venclyxto

Mechanism (SmPC section 5.1): Venetoclax selectively binds the BH3 groove of BCL-2, displacing pro-apoptotic proteins to induce mitochondrial outer membrane permeabilization, caspase activation, and programmed cell death.

## Label wording

- **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)
- **Venetoclax** (Venclyxto), Acute myeloid leukaemia, 1st line: “Venclyxto in combination with a hypomethylating agent is indicated for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (AML) who are ineligible for intensive chemotherapy.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/venclyxto-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/venetoclax