Venclyxto is a cancer medicine used to treat adults with the following blood cancers: * chronic lymphocytic leukaemia (CLL); * acute myeloid leukaemia (AML); For CLL, Venclyxto can be used: * in patients who have not previously been treated for CLL, in combination with acalabrutinib (with or without obinutuzumab), obinutuzumab or ibrutinib; * in patients who have received at least one previous treatment, in combination with rituximab; * 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 * on its own in patients who do not have these genetic changes, after treatment with chemotherapy combined with immunotherapy and a B‑cell receptor pathway inhibitor have both not worked. For AML, Venclyxto is used in combination with either azacitidine or decitabine in adults who cannot have intensive chemotherapy. Venclyxto contains the active substance venetoclax.
Therapeutic Indication
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 * 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.
Therapeutic Area (MeSH)
ATC Code
L01XX52
ATC Item
N/A
Pharmacotherapeutic Group
Antineoplastic agents
Active Substance (Summary)
INN / Common Names
EMA Name
Venclyxto
Medicine Name
Venclyxto
Aliases
N/ANo risk management plan link.
