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On 22 February 2018, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Mylotarg, intended for the treatment of acute myeloid leukaemia. Mylotarg was designated as an orphan medicinal product on 18 October 2000. The applicant for this medicinal product is Pfizer Limited.

Mylotarg will be available as a 5-mg powder for concentrate for solution for infusion. The active substance of Mylotarg is gemtuzumab ozogamicin, a humanised immunoglobulin G subtype 4 (IgG4) antibody (ATC code: L01XC05) directed at CD33 which is conjugated to calicheamicin, a toxin which induces breaks in double-stranded DNA, subsequently inducing cell cycle arrest and apoptotic cell death.

The benefit with Mylotarg is improvement in event-free survival. The most common (> 30%) side effects of Mylotarg when used together with daunorubicin and cytarabine are haemorrhage and infection.

The full indication is: “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).”

It is proposed that Mylotarg should be prescribed by physicians experienced in the use of anticancer medicinal products.

Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published in the European public assessment report (EPAR) and made available in all official European Union languages after the marketing authorisation has been granted by the European Commission.

Name Language First published Last updated
CHMP summary of positive opinion for Mylotarg (English only) 2018-02-23  

Key facts

Product details for Mylotarg
INN or common name

gemtuzumab ozogamicin

Therapeutic area Leukemia, Myeloid, Acute
Active substance

gemtuzumab ozogamicin

Date opinion adopted22/02/2018
Company name

Pfizer Limited

Application typeInitial authorisation