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 indications3

DrugBiomarker requirementRegimenSettingConditions
Chronic lymphocytic leukaemia3
Idelalisib
Zydelig
17p deletion or TP53 mutation
+ rituximab
1L
Not eligible for any other therapies
Venetoclax
Venclyxto
Absence of 17p deletion or TP53 mutation
Monotherapy
3L+
Failed both chemoimmunotherapy and a B-cell receptor pathway inhibitor
Venetoclax
Venclyxto
17p deletion or TP53 mutation
Monotherapy
Any line
After unsuitable for or have failed a B-cell receptor pathway inhibitor

TP53/del(17p) by tumour

Label wording3

The sentence from section 4.1 of the SmPC that each indication above comes from.

  1. 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
  2. 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.
  3. 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).