Dacogen
Authorised
This medicine is authorised for use in the European Union
decitabine
MedicineHumanAuthorised
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
This is a summary of the European public assessment report (EPAR) for Dacogen. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Dacogen.
Dacogen is a powder that is made up into a solution for infusion (drip) into a vein. It contains the active substance decitabine.
Dacogen is used to treat adults with newly diagnosed acute myeloid leukaemia (AML), a type of cancer affecting the white blood cells. It is used in patients who are not eligible for standard induction chemotherapy (initial treatment with cancer medicines).
Because the number of patients with AML is low, the disease is considered ‘rare’, and Dacogen was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 8 June 2006.
Dacogen can only be obtained with a prescription. Treatment with Dacogen should be started under the supervision of a doctor who has experience in the use of chemotherapy.
Dacogen is given as an infusion into a vein over one hour. The dose is calculated using the patient’s height and weight. In a 4-week treatment cycle, Dacogen is given daily for the first 5 days. At least 4 treatment cycles are recommended but they can be continued for as long as the AML remains under control. If a patient develops certain severe side effects, the doctor may decide to delay or stop Dacogen treatment.
The active substance in Dacogen, decitabine, is a cytidine deoxynucleoside analogue. This means that it is similar to cytidine deoxynucleoside, a fundamental component of the DNA (genetic material) of cells. In the body, decitabine is converted into decitabine triphosphate, which is then incorporated into the DNA where it blocks the activity of enzymes called DNA methyltransferases (DNMTs). These enzymes promote the development and progression of cancer. By blocking DNMTs, decitabine will prevent the increase of tumour cells and lead to their death.
Dacogen has been studied in one main study involving 485 adults, who were newly diagnosed with AML but were not eligible for standard induction chemotherapy. Dacogen was compared with either supportive care (any medicine or technique to help patients, excluding cancer medicines or surgery) or low-dose cytarabine (another cancer medicine). Treatment was given for as long as patients benefited from it. The main measure of effectiveness was how long the patients lived.
Patients receiving Dacogen lived for an average of 7.7 months compared with 5.0 months for patients receiving supportive care or treatment with cytarabine.
The most common side effects with Dacogen (seen in more than 35% of patients) are fever, anaemia (low red blood cell count) and thrombocytopenia (low blood platelet count). The most common serious side effects (seen in more than 20% of patients) include pneumonia (lung infection), thrombocytopenia, neutropenia (low blood count of neutrophils, a type of white blood cell), febrile neutropenia (low white blood cell count with fever) and anaemia.
Dacogen must not be used in people who are breastfeeding. As it is not known whether the active substance is excreted in breast milk, in the event that a patient is breastfeeding, they must discontinue breastfeeding if they require treatment with Dacogen.
For the full list of all restrictions and side effects reported with Dacogen, see the package leaflet.
The CHMP noted that the improvement in survival with Dacogen in patients with AML was modest but relevant, as the benefits of current treatments are limited in patients who are not eligible for standard induction chemotherapy. There were no major safety concerns with Dacogen and the overall safety profile was similar to that of low-dose cytarabine but some side effects such as infections and neutropenia were more common with Dacogen. The CHMP decided that Dacogen’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Dacogen have been included in the summary of product characteristics and the package leaflet.
The European Commission granted a marketing authorisation valid throughout the European Union for Dacogen on 20 September 2012.
For more information about treatment with Dacogen, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Product information
Latest procedure affecting product information:
N/0050
01/10/2024
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
- Dacogen
- Active substance
- decitabine
- International non-proprietary name (INN) or common name
- decitabine
- Therapeutic area (MeSH)
- Leukemia, Myeloid
- Anatomical therapeutic chemical (ATC) code
- L01BC08
Pharmacotherapeutic group
Antineoplastic agentsTherapeutic indication
Treatment of adult patients with newly diagnosed de novo or secondary acute myeloid leukaemia (AML), according to the World Health Organization (WHO) classification, who are not candidates for standard induction chemotherapy.
Topics
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