MedPath
EMA Approval

Dacogen

L01BC08

decitabine

Antineoplastic agents

decitabine

Leukemia, Myeloid

Basic Information

EMA regulatory identification and product classification information

EMA Identifiers

ATC CodeL01BC08
EMA European Classification

Overview Summary

Comprehensive product overview and regulatory summary

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.

Authorisations (1)

EMEA/H/C/002221

Janssen-Cilag International N.V.,Turnhoutseweg 30,BE-2340 Beerse,Belgium

Authorised

September 20, 2012

Active Substances (1)

decitabine

Documents (16)

Dacogen-H-C-PSUSA-00009118-201605 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation

February 28, 2017

CHANGES_SINCE_INITIAL_AUTHORISATION

Dacogen : EPAR - Public assessment report

October 15, 2012

INITIAL_MARKETING_AUTHORISATION_DOCUMENTS

CHMP summary of positive opinion for Dacogen

July 19, 2012

INITIAL_MARKETING_AUTHORISATION_DOCUMENTS

Dacogen : EPAR - Public assessment report

October 15, 2012

CHANGES_SINCE_INITIAL_AUTHORISATION

CHMP summary of positive opinion for Dacogen

July 19, 2012

CHANGES_SINCE_INITIAL_AUTHORISATION

Dacogen : EPAR - Paediatric investigation plan compliance statement

April 30, 2021

CHANGES_SINCE_INITIAL_AUTHORISATION

Dacogen-H-C-PSUSA-00009118-201805 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation

February 20, 2019

CHANGES_SINCE_INITIAL_AUTHORISATION

Dacogen-H-C-2221-PSUV-0008 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation

January 26, 2014

CHANGES_SINCE_INITIAL_AUTHORISATION

Dacogen : EPAR - Risk-management-plan summary

February 20, 2019

RISK_MANAGEMENT_PLAN_SUMMARY

Dacogen : EPAR - Procedural steps taken and scientific information after authorisation

February 3, 2013

CHANGES_SINCE_INITIAL_AUTHORISATION

Dacogen-H-C-PSUSA-00009118-202005 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation

April 30, 2021

CHANGES_SINCE_INITIAL_AUTHORISATION

Dacogen-H-C-2221-P46-008: EPAR - Assessment Report

June 6, 2016

CHANGES_SINCE_INITIAL_AUTHORISATION

Dacogen : EPAR - All Authorised presentations

October 15, 2012

AUTHORISED_PRESENTATIONS

Dacogen : EPAR - Product Information

October 15, 2012

DRUG_PRODUCT_INFORMATION

Dacogen : EPAR - Summary for the public

October 15, 2012

OVERVIEW_DOCUMENT

Dacogen-H-C-2221-PSUV-0011 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation

July 28, 2014

CHANGES_SINCE_INITIAL_AUTHORISATION

Overview Q&A (10)

Question

What is Dacogen?

Answer

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

Question

Why has Dacogen been approved?

Answer

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.

Question

How is Dacogen used?

Answer

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.

Question

How does Dacogen work?

Answer

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.

Question

What measures are being taken to ensure the safe and effective use of Dacogen?

Answer

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.

Question

Other information about Dacogen

Answer

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.

Question

How has Dacogen been studied?

Answer

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.

Question

What benefit has Dacogen shown during the studies?

Answer

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.

Question

What is Dacogen used for?

Answer

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.

Question

What is the risk associated with Dacogen?

Answer

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.

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Dacogen - EMA Approval | MedPath