Gemtuzumab ozogamicin

Gemtuzumab ozogamicin (Mylotarg, Pfizer Europe MA EEIG) has 1 EU-approved indication in 1 tumour type. It needs a biomarker result: CD33 (1).
Approved indications of Gemtuzumab ozogamicin
Biomarker requirementRegimenSettingConditions
Acute myeloid leukaemia1
CD33-positive
+ daunorubicin and cytarabine
1L
Aged 15 years and above; de novo AML; except acute promyelocytic leukaemia (APL)
Full text of section 4.1 (therapeutic indications)

MYLOTARG is indicated for combination therapy with daunorubicin (DNR) and cytarabine (AraC) for the treatment of patients aged 15 years and above with previously untreated, de novo CD33-positive acute myeloid leukaemia (AML), except acute promyelocytic leukaemia (APL) (see sections 4.4 and 5.1).

Label history

14 changes to the Mylotarg label since 2018, none of them to the indications. Newest first, in the words of EMA's record of each procedure.

Changes