人用藥品歐洲公共評估報告 (EPAR)：Venclyxto，維奈托克，授權日期：2016年12月4日，修訂版：22，狀態：已獲授權

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Venclyxto is a cancer medicine used to treat adults with the following blood cancers: For CLL, Venclyxto can be used: 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. chronic lymphocytic leukaemia (CLL);

acute myeloid leukaemia (AML); 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. English (EN) (182.29 KB – PDF) English (EN) (1.89 MB – PDF) Venclyxto: EPAR – Medicine overview Venclyxto: EPAR – Risk management plan The active substance in Venclyxto, venetoclax, attaches to a protein called BCL-2. This protein is present in high amounts in leukaemia cancer cells, where it helps the cancer cells survive and makes them resistant to cancer medicines. By attaching to BCL-2 and blocking its action, venetoclax causes cancer cells to die which helps slow down progression of the disease. Venclyxto received a conditional marketing authorisation valid throughout the EU on 5 December 2016. The conditional marketing authorisation was switched to a standard marketing authorisation on 20 November 2018. Venclyxto should be started and supervised by a doctor with experience in cancer medicines and can only be obtained with a prescription. It is available as tablets to be taken by mouth once a day with a meal. The length of treatment depends on the cancer being treated and whether Venclyxto is given with other medicines and which medicines these are. The dose may need to be reduced or treatment interrupted or stopped if certain side effects occur. For more information about using Venclyxto, see the package leaflet or contact your doctor or pharmacist. Three studies have shown that Venclyxto used in combination with other cancer medicines is effective in people with previously untreated CLL. In these studies, the main measure of effectiveness was how long people lived without their disease getting worse (progression-free survival). In the first study involving 432 patients, people treated with Venclyxto plus obinutuzumab lived longer without their disease getting worse compared with patients treated with chlorambucil (a chemotherapy medicine) plus obinutuzumab. In the second study involving 211 patients, after around 28 months of follow up, 21% of those given Venclyxto in combination with ibrutinib died or had a worsening of their disease, compared with 64% of those given a comparator treatment (chlorambucil in combination with obinutuzumab). In addition, after 64 months of follow up, 19% of those receiving Venclyxto in combination with ibrutinib had died compared with 38% of those receiving the comparator treatment. A third study involving 867 participants compared giving Venclyxto plus acalabrutinib (with or without obinutuzumab) with giving a combination of chemotherapy and immunotherapy chosen by the doctor. At the time of the analysis, 31% of those who received Venclyxto plus acalabrutinib alone and 20% of those who received Venclyxto plus acalabrutinib and obinutuzumab had their disease worsen or had died. This compared with 33% of those receiving chemotherapy and immunotherapy chosen by the doctor. Previously treated CLL with or without 17p deletion or TP53 mutation A study involving 389 patients with CLL who received at least one previous treatment showed that patients treated with Venclyxto plus rituximab lived longer without their disease getting worse than patients treated with rituximab and bendamustine (another cancer medicine). Two main studies also showed that Venclyxto used on its own is effective at partially clear cancer cells (partial response) or remove all detectable signs of cancer (complete response) in patients with previously treated CLL.