Information on how to access Mylotarg™▼ (gemtuzumab ozogamicin) and cytarabine prescribing information and adverse event reporting can be found at the bottom of the page.
*Event Free Survival (EFS) was the primary endpoint for the study. Defined as the time from randomisation to the date of assessment of response (if CR or CRp had not been achieved), relapse or death.
Median EFS was 17.3 months (95% CI: 13.4, 30.0) in the MYLOTARG arm versus 9.5 months (95% CI: 8.1, 12.0) in the DA alone arm; hazard ratio (HR) 0.562 (95% CI: 0.415, 0.762); 2-sided p=0.0002 by log-rank test.
Median RFS was 28.0 months (95% CI: 16.3, NE) in the MYLOTARG arm versus 11.4 months (95% CI; 10.0, 14.4) in the DA alone arm; hazard ration (HR) 0.526 (95% CI: 0.362, 0.764)
Watch Professor Robert Hills discuss the key clinical data from the pivotal ALFA study
Watch Dr Eleni Tholouli discuss the NICE approval for MYLOTARG and efficacy data using the ALFA schedule
CI, Confidence Intervals; CR, Complete Remission, CRp, Complete Remission with incomplete platelet recovery;
DA, daunorubicin and cytarabine; EFS: Event-free Survival, HR, Hazard Ratio; mEFS, median Event-free Survival; NE, not estimable; RFS: Relapse-free survival
▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 of the SmPC for how to report adverse reactions.
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PP-PFE-GBR-2688. December 2020