CD33

1 EU-approved indication of 1 drug needs a CD33 result, in 1 tumour type, most of them in acute myeloid leukaemia.

Approved indications1

DrugBiomarker requirementRegimenSettingConditions
Acute myeloid leukaemia1
+ daunorubicin and cytarabine
1L
Aged 15 years and above; de novo AML; except acute promyelocytic leukaemia (APL)

CD33 by tumour

Label wording1

The sentence from section 4.1 of the SmPC that each indication above comes from.

  1. Gemtuzumab ozogamicin (Mylotarg)
    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).