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 of Venetoclax
Biomarker requirementRegimenSettingConditions
Acute myeloid leukaemia1
None
+ a hypomethylating agent
1L
Ineligible for intensive chemotherapy
Chronic lymphocytic leukaemia6
None
+ acalabrutinib with or without obinutuzumab
1L
None
None
+ ibrutinib
1L
None
None
+ obinutuzumab
1L
None
None
+ rituximab
2L
After at least one prior therapy
Absence of 17p deletion or TP53 mutation
Monotherapy
3L+
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
Full text of section 4.1 (therapeutic indications)

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 Venclyxto in combination with rituximab is indicated for the treatment of adult patients with CLL who have received at least one prior therapy. 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. 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.

Label history

24 changes to the Venclyxto label since 2017, 5 of them to the indications. Newest first, in the words of EMA's record of each procedure.

Changes