Dacogen

decitabine

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.

What is Dacogen?

Dacogen is a powder that is made up into a solution for infusion (drip into a vein). It contains the active substance decitabine.

What is Dacogen used for?

Dacogen is used to treat adults aged 65 or older with acute myeloid leukaemia (AML), a type of cancer affecting the white blood cells. It is used in patients with newly diagnosed AML who are not eligible for initial treatment with standard chemotherapy (anticancer 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.

The medicine can only be obtained with a prescription.

How is Dacogen used?

Treatment with Dacogen should be started under the supervision of a doctor who has experience in the use of chemotherapy.

Dacogen is given as treatment cycles over five days, with a recommended dose of 20 mg per square metre body surface area (calculated using the patient’s height and weight) per day. Dacogen is given as an infusion into a vein over one hour. This treatment cycle should be repeated every four weeks depending on how well the patient responds to and tolerates treatment. If a patient develops certain severe side effects, the doctor may decide to delay treatment.

Patients should be treated for a minimum of four cycles and the doctor may continue treatment with Dacogen for as long as there is a benefit from the treatment.

How does Dacogen work?

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 genetic material of cells. In the body, decitabine is converted into decitabine triphosphate, which is then incorporated into the DNA (genetic material) where it blocks the activity of enzymes called DNA methyltransferases (DNMTs), which are responsible for promoting the development and progression of cancer. By blocking DNMTs, decitabine will block the division of tumour cells and lead to their death.

How has Dacogen been studied?

The effects of Dacogen were first tested in experimental models before being studied in humans.

Dacogen has been studied in one main study involving 485 adults aged 65 or older, who were newly diagnosed with AML. Dacogen was compared with either supportive care (any medicine or technique to help patients, excluding anticancer medicines or surgery) or low-dose cytarabine (another anticancer medicine). Treatment was given for as long as patients benefited from it. The main measure of effectiveness was how long the patients lived.

What benefit has Dacogen shown during the studies?

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.

What is the risk associated with Dacogen?

The most common side effects with Dacogen (seen in more than 35% of patients) are pyrexia (fever), anaemia (low red blood cell count) and thrombocytopenia (low blood count of platelets). The most common serious side effects (seen in more than 20% of patients) include pneumonia (infection of the lungs), thrombocytopenia, neutropenia (low blood count of neutrophils, a type of white blood cell), febrile neutropenia (low white-blood-cell count with fever) and anaemia. For the full list of all side effects reported with Dacogen, see the package leaflet.

Dacogen must not be used in people who are hypersensitive (allergic) to decitabine or any of the other ingredients. 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.

Why has Dacogen been approved?

The CHMP noted that the improvement in survival seen with Dacogen in patients with AML was modest but relevant, as the benefits of currently available treatments are limited in adults aged 65 years or older. In addition, there were no major safety concerns with Dacogen and the overall safety profile was similar to that of low-dose cytarabine with the exception of some side effects such as infections and neutropenia, which 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.

Other information about Dacogen

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.

This EPAR was last updated on 04/02/2013 .

More detail is available in the summary of product characteristics

Product details

Publication details

Product information

11/01/2013  Dacogen -EMEA/H/C/002221 -N/0002

Contents

• Annex I - Summary of product characteristics
• Annex IIA - Manufacturing-authorisation holder responsible for batch release
• Annex IIB - Conditions of the marketing authorisation
• Annex IIIA - Labelling
• Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

Treatment of adult patients aged 65 years and above 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.

Changes since initial authorisation of medicine

Initial marketing-authorisation documents