Mylotarg

gemtuzumab ozogamicin

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About

An overview of Mylotarg and why it is authorised in the EU

Mylotarg is a medicine used to treat a blood cancer called acute myeloid leukaemia (AML) in patients aged 15 years and above who are newly diagnosed and have not tried other treatments.

It is used in combination with daunorubicin and cytarabine (other cancer medicines).

Mylotarg is used in patients with a protein called CD33 on their cancer cells (which is the case in most patients with AML). It is not used for a type of AML called acute promyelocytic leukaemia (APL).

AML is rare, and Mylotarg was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 18 October 2000. 

Mylotarg contains the active substance gemtuzumab ozogamicin.

How is Mylotarg used?

Mylotarg is given as an infusion into a vein lasting 2 hours. The patient usually receives 3 infusions within one week. The patient will also be given two other medicines: daunorubicin and cytarabine.

If the cancer responds to initial treatment, the patient may receive further ‘consolidation’ treatment to keep the cancer from coming back.

Mylotarg infusions must be given in a place (such as a hospital) where the patient can be resuscitated if there are severe reactions. The patient is also given medicines to help prevent reactions such as reddening of the skin, chills and fever.

For more information about using Mylotarg, see the package leaflet or contact your doctor or pharmacist. Mylotarg can only be obtained with a prescription.

How does Mylotarg work?

The active substance in Mylotarg, gemtuzumab ozogamicin, consists of two parts: a cytotoxic (cell-killing) substance and a monoclonal antibody (a type of protein).

The monoclonal antibody part (gemtuzumab) has been designed to attach to CD33. When the antibody attaches to CD33 on leukaemia cells, the cells absorb the antibody, as well as the cytotoxic substance that it is attached to. Inside the cells, the cytotoxic substance, which is called calicheamicin, is released. The calicheamicin then breaks up the cells’ DNA, eventually killing the cells.

What benefits of Mylotarg have been shown in studies?

A main study in 271 patients with AML has shown that adding Mylotarg to daunorubicin and cytarabine can prolong the time patients live without their cancer coming back by around 8 months.

In patients receiving Mylotarg in combination with daunorubicin and cytarabine, it took an average of 17.3 months until the treatment failed, the cancer came back or the patient died, compared with 9.5 months in patients receiving a combination of only daunorubicin and cytarabine.

What are the risks associated with Mylotarg?

The most common side effects with Mylotarg when given in combination with daunorubicin and cytarabine (which may affect more than 3 in 10 people) are bleeding and severe infections. These side effects can be serious in more than 1 in 10 people. Other serious side effects with the combination therapy are liver disease, including veno-occlusive disease (a liver injury), and tumour lysis syndrome (a complication due to the breakdown of cancer cells).

For the full list of side effects and restrictions with Mylotarg, see the package leaflet.

Why is Mylotarg authorised in the EU?

Mylotarg, given in combination with daunorubicin and cytarabine, has been shown to prolong the time patients lived before the cancer came back by up to 8 months. Although some side effects with Mylotarg can be serious, they were considered acceptable in light of the severity of the patients’ condition.

The European Medicines Agency decided that Mylotarg’s benefits are greater than its risks and it can be authorised for use in the EU.

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

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Mylotarg have been included in the summary of product characteristics and the package leaflet.

As for all medicines, data on the use of Mylotarg are continuously monitored. Side effects reported with Mylotarg are carefully evaluated and any necessary action taken to protect patients.

Other information about Mylotarg

Mylotarg received a marketing authorisation valid throughout the EU on 19 April 2018.

Name Language First published Last updated
Mylotarg : EPAR - Summary for the public BG = bălgarski 2018-05-04  
Mylotarg : EPAR - Summary for the public ES = español 2018-05-04  
Mylotarg : EPAR - Summary for the public CS = čeština 2018-05-04  
Mylotarg : EPAR - Summary for the public DA = dansk 2018-05-04  
Mylotarg : EPAR - Summary for the public DE = Deutsch 2018-05-04  
Mylotarg : EPAR - Summary for the public ET = eesti keel 2018-05-04  
Mylotarg : EPAR - Summary for the public EL = elliniká 2018-05-04  
Mylotarg : EPAR - Summary for the public EN = English 2018-05-04  
Mylotarg : EPAR - Summary for the public FR = français 2018-05-04  
Mylotarg : EPAR - Summary for the public IT = italiano 2018-05-04  
Mylotarg : EPAR - Summary for the public LV = latviešu valoda 2018-05-04  
Mylotarg : EPAR - Summary for the public LT = lietuvių kalba 2018-05-04  
Mylotarg : EPAR - Summary for the public HU = magyar 2018-05-04  
Mylotarg : EPAR - Summary for the public MT = Malti 2018-05-04  
Mylotarg : EPAR - Summary for the public NL = Nederlands 2018-05-04  
Mylotarg : EPAR - Summary for the public PL = polski 2018-05-04  
Mylotarg : EPAR - Summary for the public PT = português 2018-05-04  
Mylotarg : EPAR - Summary for the public RO = română 2018-05-04  
Mylotarg : EPAR - Summary for the public SK = slovenčina 2018-05-04  
Mylotarg : EPAR - Summary for the public SL = slovenščina 2018-05-04  
Mylotarg : EPAR - Summary for the public FI = suomi 2018-05-04  
Mylotarg : EPAR - Summary for the public SV = svenska 2018-05-04  
Mylotarg : EPAR - Summary for the public HR = Hrvatski 2018-05-04  

This EPAR was last updated on 04/05/2018 .

Authorisation details

Product details

Product details for Mylotarg
NameMylotarg
Agency product numberEMEA/H/C/004204
Active substance

gemtuzumab ozogamicin

International non-proprietary name (INN) or common name

gemtuzumab ozogamicin

Therapeutic area Leukemia, Myeloid, Acute
Anatomical therapeutic chemical (ATC) code L01XC05
Additional monitoring

This medicine is under additional monitoring. This means that it is being monitored even more intensively than other medicines. For more information, see medicines under additional monitoring.

Treatment of rare diseases

This medicine has an "orphan designation" which means that it is used to treat life-threatening or chronically debilitating conditions that affect no more than five in 10,000 people in the European Union, or are medicines which, for economic reasons, would be unlikely to be developed without incentives.

Publication details

Publication details for Mylotarg
Marketing-authorisation holder

Pfizer Limited

Revision0
Date of issue of marketing authorisation valid throughout the European Union19/04/2018

Contact address:

Pfizer Limited
Ramsgate Road 
Sandwich 
Kent 
CT13 9NJ 
United Kingdom
 

Product information

Product information

19/04/2018  Mylotarg -EMEA/H/C/004204 --

Name Language First published Last updated
Mylotarg : EPAR - Product Information HR = Hrvatski 2018-05-04  
Mylotarg : EPAR - Product Information HR = Hrvatski 2018-05-04  
Mylotarg : EPAR - Product Information HR = Hrvatski 2018-05-04  
Mylotarg : EPAR - Product Information HR = Hrvatski 2018-05-04  
Mylotarg : EPAR - Product Information HR = Hrvatski 2018-05-04  
Mylotarg : EPAR - Product Information HR = Hrvatski 2018-05-04  
Mylotarg : EPAR - Product Information HR = Hrvatski 2018-05-04  
Mylotarg : EPAR - Product Information HR = Hrvatski 2018-05-04  
Mylotarg : EPAR - Product Information HR = Hrvatski 2018-05-04  
Mylotarg : EPAR - Product Information HR = Hrvatski 2018-05-04  
Mylotarg : EPAR - Product Information HR = Hrvatski 2018-05-04  
Mylotarg : EPAR - Product Information HR = Hrvatski 2018-05-04  
Mylotarg : EPAR - Product Information HR = Hrvatski 2018-05-04  
Mylotarg : EPAR - Product Information HR = Hrvatski 2018-05-04  
Mylotarg : EPAR - Product Information HR = Hrvatski 2018-05-04  
Mylotarg : EPAR - Product Information HR = Hrvatski 2018-05-04  
Mylotarg : EPAR - Product Information HR = Hrvatski 2018-05-04  
Mylotarg : EPAR - Product Information HR = Hrvatski 2018-05-04  
Mylotarg : EPAR - Product Information HR = Hrvatski 2018-05-04  
Mylotarg : EPAR - Product Information HR = Hrvatski 2018-05-04  
Mylotarg : EPAR - Product Information HR = Hrvatski 2018-05-04  
Mylotarg : EPAR - Product Information HR = Hrvatski 2018-05-04  
Mylotarg : EPAR - Product Information HR = Hrvatski 2018-05-04  
Mylotarg : EPAR - Product Information HR = Hrvatski 2018-05-04  
Mylotarg : EPAR - Product Information HR = Hrvatski 2018-05-04  

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.


Name Language First published Last updated
Mylotarg : EPAR - All Authorised presentations HR = Hrvatski 2018-05-04  
Mylotarg : EPAR - All Authorised presentations HR = Hrvatski 2018-05-04  
Mylotarg : EPAR - All Authorised presentations HR = Hrvatski 2018-05-04  
Mylotarg : EPAR - All Authorised presentations HR = Hrvatski 2018-05-04  
Mylotarg : EPAR - All Authorised presentations HR = Hrvatski 2018-05-04  
Mylotarg : EPAR - All Authorised presentations HR = Hrvatski 2018-05-04  
Mylotarg : EPAR - All Authorised presentations HR = Hrvatski 2018-05-04  
Mylotarg : EPAR - All Authorised presentations HR = Hrvatski 2018-05-04  
Mylotarg : EPAR - All Authorised presentations HR = Hrvatski 2018-05-04  
Mylotarg : EPAR - All Authorised presentations HR = Hrvatski 2018-05-04  
Mylotarg : EPAR - All Authorised presentations HR = Hrvatski 2018-05-04  
Mylotarg : EPAR - All Authorised presentations HR = Hrvatski 2018-05-04  
Mylotarg : EPAR - All Authorised presentations HR = Hrvatski 2018-05-04  
Mylotarg : EPAR - All Authorised presentations HR = Hrvatski 2018-05-04  
Mylotarg : EPAR - All Authorised presentations HR = Hrvatski 2018-05-04  
Mylotarg : EPAR - All Authorised presentations HR = Hrvatski 2018-05-04  
Mylotarg : EPAR - All Authorised presentations HR = Hrvatski 2018-05-04  
Mylotarg : EPAR - All Authorised presentations HR = Hrvatski 2018-05-04  
Mylotarg : EPAR - All Authorised presentations HR = Hrvatski 2018-05-04  
Mylotarg : EPAR - All Authorised presentations HR = Hrvatski 2018-05-04  
Mylotarg : EPAR - All Authorised presentations HR = Hrvatski 2018-05-04  
Mylotarg : EPAR - All Authorised presentations HR = Hrvatski 2018-05-04  
Mylotarg : EPAR - All Authorised presentations HR = Hrvatski 2018-05-04  
Mylotarg : EPAR - All Authorised presentations HR = Hrvatski 2018-05-04  
Mylotarg : EPAR - All Authorised presentations HR = Hrvatski 2018-05-04  

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

Mylotarg is indicated for combination therapy with daunorubicin (DNR) and cytarabine (AraC) for the treatment of patients age 15 years and above with previously untreated, de novo CD33-positive acute myeloid leukaemia (AML), except acute promyelocytic leukaemia (APL).

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated

Initial marketing-authorisation documents

Name Language First published Last updated
Mylotarg : Orphan maintenance assessment report HR = Hrvatski 2018-05-04  
Mylotarg : EPAR - Public assessment report HR = Hrvatski 2018-05-04  
CHMP summary of positive opinion for Mylotarg HR = Hrvatski 2018-02-23  

Authorised

This medicine is approved for use in the European Union

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