TP53/del(17p) in chronic lymphocytic leukaemia
3 EU-approved indications in chronic lymphocytic leukaemia need a TP53/del(17p) result: venetoclax (any line), venetoclax (3rd line+) and idelalisib (1st line).
Line of therapy
| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| TP53/del(17p) mutation2 | ||||
Zydelig | 17p deletion or TP53 mutation | + rituximab | 1L | Not eligible for any other therapies |
Venclyxto | 17p deletion or TP53 mutation | Monotherapy | Any line | After unsuitable for or have failed a B-cell receptor pathway inhibitor |
| 17p/TP53 negative1 | ||||
Venclyxto | Absence of 17p deletion or TP53 mutation | Monotherapy | 3L+ | Failed both chemoimmunotherapy and a B-cell receptor pathway inhibitor |
20 approvals for CLL need no biomarker and apply whatever the result. All approvals for CLL
See also
Label wording3
The sentence from section 4.1 of the SmPC that each indication above comes from.
- Venetoclax (Venclyxto)
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
- Venetoclax (Venclyxto)
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.
- Idelalisib (Zydelig)
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).