# TP53/del(17p)

3 EU-approved indications of 2 drugs need a TP53/del(17p) result, in 1 tumour type, most of them in chronic lymphocytic leukaemia.

## Approved indications by tumour

### Chronic lymphocytic leukaemia

| 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) | Absence of 17p deletion or TP53 mutation | Monotherapy | 3rd line+ | Failed both chemoimmunotherapy and a B-cell receptor pathway inhibitor |
| [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 |

## Label wording

- **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)
- **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/biomarkers/tp53-del-17p