Mylotarg (gemtuzumab ozogamicin) granted approval in the EU for use in previously untreated, de novo, CD33-positive AML

On 23^rd April 2018, the European Commission (EC) granted approval to Mylotarg (gemtuzumab ozogamicin), an antibody drug conjugate (ADC), in combination with daunorubicin and cytarabine for the treatment of patients  aged 15 years and above with previously untreated, de novo, CD33-positive acute myeloid leukemia (AML).¹ This approval comes after the ‘positive opinion’ recommendation of Mylotarg by the European Medicines Agency(EMA) Committee for Medicinal Products for Human Use (CHMP) in February 2018 and the U.S. Food and Drug Administration (FDA) approval in September 2017.

The approval by the EC for Mylotarg was based on results obtained from the phase III ALFA-701 study (NCT00927498). Data from the ALFA-701 study showed that combination of Mylotarg with standard chemotherapy regimen in newly diagnosed de novo AML patients significantly improved 3-year Event Free Survival (EFS) and Relapse Free Survival (RFS) compared to chemotherapy alone.²

Mylotarg’s manufacturers, Pfizer, noted that Mylotarg “is the first and only AML therapy approved in the European Union (EU) that targets CD33, an antigen expressed on AML cells in up to 90% of patients”.¹