Vanflyta
Authorised
This medicine is authorised for use in the European Union
quizartinib
MedicineHumanAuthorised
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
Vanflyta is a cancer medicine used to treat adults who have been newly diagnosed with acute myeloid leukaemia (AML), a cancer of the white blood cells. It is only given to those patients whose cancer cells have a particular change (mutation) known as ITD in the gene for a protein called FLT3.
Vanflyta is used together with cytarabine and anthracycline (other cancer medicines, also called chemotherapy) at induction (start of treatment) . After induction it is used in combination with cytarabine alone (consolidation). It is then used on its own as maintenance therapy.
Vanflyta contains the active substance quizartinib.
Vanflyta can only be obtained with a prescription and treatment should be started by a doctor experienced in using cancer treatments.
Before taking Vanflyta, the patient must have a test to confirm that their cancer cells have the ITD mutation in the FLT3 gene (ITD-FLT3 positive).
Vanflyta is available as tablets to be taken by mouth. It is taken once a day for two weeks during each 4-week chemotherapy cycle. After chemotherapy is complete, Vanflyta is taken once a day on its own as maintenance treatment. Treatment can continue for up to 36 cycles lasting 4 weeks each.
For more information about using Vanflyta, see the package leaflet or contact your doctor or pharmacist.
The active substance in Vanflyta, quizartinib, blocks the action of enzymes known as tyrosine kinases, in particular a tyrosine kinase called FLT3 that normally controls growth and division of white blood cells. In patients who have an FLT3 mutation, the FLT3 enzyme is overactive and stimulates the growth of too many white blood cells. By blocking FLT3, quizartinib is expected to stop the growth of white blood cells and thus slow down the development of the cancer.
A main study involving 539 patients newly diagnosed with AML compared Vanflyta with placebo (a dummy treatment). Patients were given Vanflyta or placebo in combination with chemotherapy. Those whose cancer responded to treatment either continued their treatment without chemotherapy or had a blood stem cell transplant before continuing their treatment. After three years of treatment, 50% of patients who received Vanflyta were still alive compared with 41% of those who received placebo.
For the full list of side effects and restrictions with Vanflyta, see the package leaflet.
The most common side effects with Vanflyta (which may affect more than 1 in 5 people) include increased levels of an enzyme in the blood called alanine aminotransferase, decreased levels of blood platelets, decreased levels of haemoglobin (the protein in red blood cells that carries oxygen around the body), diarrhoea, nausea (feeling sick), abdominal (belly) pain, headache, vomiting and decreased levels of neutrophils (a type of white blood cell).
The most common serious side effect with Vanflyta (which may affect up more than 1 in 10 people) is neutropenia (low levels of neutrophils). Other common serious side effects (which may affect up to 1 in 10 people) include fungal infections and herpes infections.
The most common serious side effects with Vanflyta (which may affect up to 1 in 10 people) that led to dose reduction or interruption include neutropenia, thrombocytopenia (low levels of blood platelets) and prolonged QT interval (abnormal electrical activity of the heart that affects its rhythm).
Vanflyta should not be used by patients who are breast-feeding or who have congenital long QT syndrome (abnormal electrical activity of the heart caused by a gene defect).
When used in combination with chemotherapy, Vanflyta has been shown to prolong the lives of people newly diagnosed with ITD-FLT3-positive AML. Although some of the medicine’s side effects can be serious, the Agency considered that adequate measures were in place to manage or minimise the risks with Vanflyta.
The European Medicines Agency therefore decided that Vanflyta’s benefits are greater than its risks and it can be authorised for use in the EU.
The company that markets Vanflyta will provide educational materials for healthcare professionals and patients on how to minimise the risk of prolonged QT interval and recognise signs and symptoms of this side effect.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Vanflyta have also been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Vanflyta are continuously monitored. Suspected side effects reported with Vanflyta are carefully evaluated and any necessary action taken to protect patients.
Vanflyta received a marketing authorisation valid throughout the EU on 6 November 2023.
Product information
Latest procedure affecting product information:
IB/0005
16/12/2024
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
- Vanflyta
- Active substance
- Quizartinib dihydrochloride
- International non-proprietary name (INN) or common name
- quizartinib
- Therapeutic area (MeSH)
- Leukemia, Myeloid
- Anatomical therapeutic chemical (ATC) code
- L01EX11
Pharmacotherapeutic group
- Antineoplastic agents
- Protein kinase inhibitors
Therapeutic indication
Vanflyta is indicated in combination with standard cytarabine and anthracycline induction and standard cytarabine consolidation chemotherapy, followed by Vanflyta single-agent maintenance therapy for adult patients with newly diagnosed acute myeloid leukaemia (AML) that is FLT3-ITD positive.
News on Vanflyta
This page was last updated on