Dosing and Administration

In the ALFA-0701 study, fractionated doses of MYLOTARG in combination with standard front-line chemotherapy were shown to significantly improve EFS in patients with de novo AML compared to standard front-line chemotherapy alone.^*†1

Dosing and administration information
 

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 AML, except acute promyelocytic leukaemia.²
 

The recommended induction course of MYLOTARG is given as an IV infusion over a 2-hour period on days 1, 4 and 7, in combination with DNR infused over 30 minutes on days 1 to 3, and AraC by continuous infusion on days 1 to 7.²

MYLOTARG dose capped at one 5mg vial for all regimens described below.

For patients who do not experience a complete remission (CR)^‡ after induction, a second induction may be required. MYLOTARG should not be administered during a second induction if a second induction is not required.^1,2

For patients experiencing a CR^‡ after induction, up to two consolidation courses are recommended.²

^*Median EFS with MYLOTARG + standard front-line chemotherapy was 17.3 months; median EFS with standard front-line chemotherapy was 9.5 months. HR=0.56 (95% CI: 0.42-0.76); p=0.0002).^1,2
 

^†EFS was the primary outcome of the ALFA-0701 study, defined as the time from randomisation to relapse, death from any cause, or failure to achieve complete remission (CR) or CR with incomplete platelet recovery (CRp). EFS was investigator-assessed. Data cutoff date: 1 August 2011; median overall follow-up was 14.8 months (20.0 months in alive patients).<sup>1

‡</sup>Defined as <5% blasts in a normocellular marrow and an ANC of >1.0 × 10⁹ cells/L with a platelet count of ≥100 × 10⁹/L in the peripheral blood in the absence of transfusion. Original study allowed consolidation for patients with a complete remission with incomplete platelet recovery (CRp) but dosing modifications preclude the use of MYLOTARG for consolidation in patients with a platelet count of <100,000/mm³.^2,3
 

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Abbreviations:
AML, acute myeloid leukaemia; ANC, absolute neutrophil count; CR, complete remission; EFS, event‑free survival; HCP, Healthcare Professional; IV, intravenous; OS, overall survival; RFS, relapse‑free survival; SmPC, Summary of Product Characteristics

References:

1.      Lambert J, et al. Haematologica 2019;104(1):113-119.

2.     MYLOTARG Summary of Product Characteristics for the United Kingdom click here. 
3.     Castaigne S, et al. Lancet 2012;379:1508–1516.

PP-MYL-GBR-1039. May 2026