CD33 in acute myeloid leukaemia
1 EU-approved indication in acute myeloid leukaemia needs a CD33 result: gemtuzumab ozogamicin (1st line).
Subtype
| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| CD33-positive1 | ||||
Mylotarg | + daunorubicin and cytarabine | 1L | Aged 15 years and above; de novo AML; except acute promyelocytic leukaemia (APL) | |
2 approvals for AML need no biomarker and apply whatever the result. All approvals for AML
See also
Label wording1
The sentence from section 4.1 of the SmPC that each indication above comes from.
- 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).