Mylotarg re-submitted to the FDA and EMA for regulatory review in AML

Antibody-Drug Conjugate (ADC) Mylotarg has been re-submitted for regulatory review at the U.S Food & Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of Acute Myeloid Leukemia (AML). Mylotarg was voluntarily withdrawn from market on October 15 2010 for the treatment of AML patients. 

ADC Mylotarg (gemtuzumab ozogamicin) is an antibody-targeted chemotherapeutic agent consisting of a humanized murine CD33 antibody. Since it is a humanized anti-CD33 monoclonal antibody, it is highly specific for targeting leukemic blasts. Mylotarg binds to, and is internalized by, tumor cells expressing CD33. As a result, this ADC can then dispense the anti-tumor antibiotic calicheamicin to CD33-expressing tumor cells¹.

According to Biopharma, the FDA has accepted to review the submission of a Biologics Licence application for the ADC based on the data obtained from the phase III ALFA-701 study. Data from the ALFA-701 study showed that combination of Mylotarg with standard chemotherapy regimen in adult AML patients significantly improved 3-year Event Free Survival (EFS) and Relapse Free Survival (RFS) compared to chemotherapy alone².

Currently, Mylotarg is being explored in multiple clinical trial studies in AML, Acute Promyelocytic Leukemia (APL), and Myelodysplastic Syndrome (MDS) patients.