Basic Information
Venclyxto
Regulatory Information
EMEA/H/C/004106
December 4, 2016
20
September 3, 2024
Company Information
Germany
Knollstrasse 67061 Ludwigshafen
AbbVie Deutschland GmbH & Co. KG
Drug Classification
Active Substances Detail
EMA Resources
Detailed Information
Therapeutic Indication
### Therapeutic indication Venclyxto in combination with obinutuzumab is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL) (see section 5.1). 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.
Overview Summary
Venclyxto is a cancer medicine used to treat adults with the following blood cancers: - chronic lymphocytic leukaemia (CLL). - acute myeloid leukaemia (AML). For CLL, it is used either in combination with other cancer medicines or on its own. Venclyxto can be used with obinutuzumab in patients who have not previously been treated for CLL or with rituximab in patients who have received at least one previous treatment. Obinutuzumab and rituximab are immunotherapy medicines (medicines that act through the body’s defence system). It can also be used on its own in: - patients with particular genetic changes (17p deletion or TP53 mutation) who cannot be treated with medicines known as B‑cell receptor pathway inhibitors (ibrutinib and idelalisib) or if these medicines have stopped working. - patients who do not have these genetic changes, after treatments with chemotherapy combined with immunotherapy as well as a B‑cell receptor pathway inhibitor have both not worked. For AML, Venclyxto is used in combination with either azacitidine or decitabinein adults who cannot have intensive chemotherapy. Venclyxto contains the active substance venetoclax.