Venclyxto
Authorised
This medicine is authorised for use in the European Union
venetoclax
MedicineHumanAuthorised
French is available via eTranslation, the European Commission's machine translation service.
Translate to French | Important information about machine translation
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
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.
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.
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.
Previously untreated CLL
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.
In the first study involving 107 previously treated patients with CLL and 17p deletion, 75% responded partially or completely to Venclyxto. In the second study involving 127 patients with or without 17p deletion or TP53 mutation, 70% of patients responded partially or completely. Patients in this second study had all previously taken B‑cell receptor pathway inhibitors.
AML
A study involving 431 patients with AML who had not previously been treated for the disease found that 65% of patients treated with Venclyxto plus azacitidine had no detectable signs of the disease (complete response), with or without recovery of blood cells, compared with 25% of patients treated with azacitidine alone. Patients lived for an average of 15 months with Venclyxto plus azacitidine compared with 10 months with azacitidine alone.
Studies carried out with Venclyxto are described in more detail in the medicine’s assessment reports.
For the full list of side effects and restrictions with Venclyxto, see the package leaflet.
For CLL, the most common side effects with Venclyxto (which may affect more than 1 in 10 people) include pneumonia (lung infection), upper respiratory tract infection (infection of the nose and throat), urinary tract infection (infection of the parts of the body that collect and pass out urine), neutropenia (low levels of neutrophils, a type of white blood cell), anaemia (low levels of red blood cells), lymphopenia (low levels of lymphocytes, a type of white blood cell), hyperkalaemia (high blood potassium levels), hyperphosphataemia (high blood phosphate levels), hypocalcaemia (low blood calcium levels), diarrhoea, vomiting, nausea (feeling sick), constipation and fatigue (tiredness). Some side effects can be serious. The most common serious side effects (which may affect more than 1 in 10 people) include pneumonia, febrile neutropenia (fever with low levels of neutrophils), sepsis (blood poisoning), neutropenia, anaemia, diarrhoea and tumour lysis syndrome (complications caused by the breakdown of cancer cells).
For AML, the most common side effects with Venclyxto (which may affect more than 1 in 10 people) include pneumonia, sepsis, urinary tract infection, neutropenia, febrile neutropenia, anaemia, thrombocytopenia (low levels of blood platelets), hypokalaemia (low blood potassium levels), decreased appetite, dizziness, syncope (fainting), headache, hypotension (low blood pressure), haemorrhage (bleeding), dyspnoea (difficulty breathing), nausea, diarrhoea, vomiting, stomatitis (inflammation of the lining of the mouth), abdominal (belly) pain, joint pain, fatigue, asthenia (weakness), weight loss and increased blood levels of bilirubin (a breakdown product of red blood cells). The most common serious side effects (which may affect more than 1 in 20 people) include febrile neutropenia, pneumonia, bacteraemia (bacteria in the blood), sepsis and haemorrhage.
Venclyxto must not be used with St. John’s wort (a herbal remedy used to treat anxiety and depression). When used for CLL, Venclyxto must also not be used with medicines called strong CYP3A inhibitors during the early stages of treatment.
The European Medicines Agency decided that Venclyxto's benefits are greater than its risks and it can be authorised for use in the EU.
For people with previously untreated CLL, studies showed that Venclyxto used in combination with acalabrutinib with or without obinutuzumab, obinutuzumab or ibrutinib prolonged the time patients lived without their disease getting worse. Regarding the combination with obinutuzumab, it is a reasonable treatment option and offers the possibility of avoiding side effects of chemotherapy medicines.
For people with previously treated CLL, studies showed that Venclyxto used in combination with rituximab prolonged the time patients lived without their disease getting worse. Studies also showed that Venclyxto used on its own can partially or completely clear detectable signs of cancer cells in patients with 17p deletion or TP53 mutation and in patients with or without these genetic changes for whom B-cell receptor pathway inhibitors did not work or are unsuitable.
For AML, Venclyxto prolonged the time patients lived when given with azacitidine. Because decitabine is a medicine with similar characteristics to azacitidine, EMA also considered that similar benefits are expected with decitabine.
Regarding safety, the side effects of Venclyxto are considered acceptable for a cancer medicine. Although there is a risk of tumour lysis syndrome, a complication that occurs when the cancer cells are being destroyed too quickly, this risk can be contained through preventive measures, such as increasing the dose gradually or reducing the dose, if needed.
The company that markets Venclyxto will provide educational materials to healthcare professionals and patients on the risk of tumour lysis syndrome. The materials will include information on how to reduce this risk, which symptoms to watch for and when to seek immediate medical attention.
Patients will also receive a patient card with important safety information to carry with them at all times.
These materials may be made available by national competent authorities on their websites. A list of national repositories is available on the EMA website.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Venclyxto have also been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Venclyxto are continuously monitored. Side effects reported with Venclyxto are carefully evaluated and any necessary action taken to protect patients.
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.
Product information
Latest procedure affecting product information:VR/0000322237 & VR/0000322240
27/05/2026
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- Venclyxto
- Active substance
- venetoclax
- International non-proprietary name (INN) or common name
- venetoclax
- Therapeutic area (MeSH)
- Leukemia, Lymphocytic, Chronic, B-Cell
- Anatomical therapeutic chemical (ATC) code
- L01XX52
Pharmacotherapeutic group
Antineoplastic agentsTherapeutic 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.
Assessment history
News on Venclyxto
This page was last updated on