Mylotarg
Authorised
This medicine is authorised for use in the European Union
gemtuzumab ozogamicin
MedicineHumanAuthorised
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
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.
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.
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.
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.
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.
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.
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.
Mylotarg received a marketing authorisation valid throughout the EU on 19 April 2018.
Product information
Latest procedure affecting product information:
II/0030
12/10/2023
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
- Mylotarg
- Active substance
- gemtuzumab ozogamicin
- International non-proprietary name (INN) or common name
- gemtuzumab ozogamicin
- Therapeutic area (MeSH)
- Leukemia, Myeloid, Acute
Pharmacotherapeutic group
Antineoplastic agentsTherapeutic 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).
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