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).
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 |
| No biomarker required20 | ||||
Calquence | None | + obinutuzumab | 1L | None |
Calquence | None | + venetoclax with or without obinutuzumab | 1L | None |
Calquence | None | Monotherapy | 1L | None |
Imbruvica | None | + obinutuzumab | 1L | None |
Imbruvica | None | + rituximab | 1L | None |
Imbruvica | None | + venetoclax | 1L | None |
Imbruvica | None | Monotherapy | 1L | None |
Gazyvaro | None | + chlorambucil | 1L | Comorbidities making them unsuitable for full-dose fludarabine based therapy |
MabThera | None | + chemotherapy | 1L | None |
Venclyxto | None | + acalabrutinib with or without obinutuzumab | 1L | None |
Venclyxto | None | + ibrutinib | 1L | None |
Venclyxto | None | + obinutuzumab | 1L | None |
Calquence | None | Monotherapy | 2L | After at least one prior therapy |
Imbruvica | None | + bendamustine and rituximab (BR) | 2L | After at least one prior therapy |
Imbruvica | None | Monotherapy | 2L | After at least one prior therapy |
Zydelig | None | + rituximab | 2L | After at least one prior therapy |
MabThera | None | + chemotherapy | 2L | Relapsed or refractory CLL |
Venclyxto | None | + rituximab | 2L | After at least one prior therapy |
Jaypircaconditional | None | Monotherapy | Any line | None |
Brukinsa | None | Monotherapy | Any line | None |
Biomarkers in chronic lymphocytic leukaemia
Label wording23
The sentence from section 4.1 of the SmPC that each indication above comes from.
- Zanubrutinib (Brukinsa)
BRUKINSA as monotherapy is indicated for the treatment of adult patients with chronic lymphocytic leukemia (CLL).
- Ibrutinib (Imbruvica)
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).
- Ibrutinib (Imbruvica)
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).
- Ibrutinib (Imbruvica)
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).
- Ibrutinib (Imbruvica)
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).
- Ibrutinib (Imbruvica)
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.
- Ibrutinib (Imbruvica)
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.
- Acalabrutinib (Calquence)
Calquence as monotherapy or in combination with obinutuzumab is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL).
- Acalabrutinib (Calquence)
Calquence as monotherapy or in combination with obinutuzumab is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL).
- Acalabrutinib (Calquence)
Calquence in combination with venetoclax with or without obinutuzumab is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL).
- Acalabrutinib (Calquence)
Calquence as monotherapy is indicated for the treatment of adult patients with chronic lymphocytic leukaemia (CLL) who have received at least one prior therapy.
- Rituximab (MabThera)
MabThera in combination with chemotherapy is indicated for the treatment of adult patients with previously untreated and relapsed/refractory CLL.
- Rituximab (MabThera)
MabThera in combination with chemotherapy is indicated for the treatment of adult patients with previously untreated and relapsed/refractory CLL.
- Pirtobrutinib (Jaypirca)
Jaypirca as monotherapy is indicated for the treatment of adult patients with chronic lymphocytic leukaemia (CLL).
- Venetoclax (Venclyxto)
Venclyxto is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL): • in combination with acalabrutinib with or without obinutuzumab
- Venetoclax (Venclyxto)
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)
- Venetoclax (Venclyxto)
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
- Venetoclax (Venclyxto)
Venclyxto in combination with rituximab is indicated for the treatment of adult patients with CLL who have received at least one prior therapy.
- 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.
- Obinutuzumab (Gazyvaro)
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).
- 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).
- 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).