Pfizer announces European Commission approval of Mylotarg combination
Pfizer announced that the European Commission has approved Mylotarg in combination with daunorubicin and cytarabine for the treatment of patients age 15 years and above with previously untreated, de novo, CD33-positive acute myeloid leukemia, or AML, except acute promyelocytic leukemia. Mylotarg is the first and only AML therapy approved in the European Union, or EU, that targets CD33, an antigen expressed on AML cells in up to 90% of patients. The goal of AML treatment is for the patient to achieve a complete, prolonged remission. Longer periods of remission prior to relapse are associated with better long-term outcomes for patients. Thus, medicines that delay the time until the disease comes back and extend life can provide meaningful clinical benefit. The European Commission's approval of Mylotarg was based on data from an investigator-led, Phase 3 randomized, open-label study in previously untreated, de novo patients. Mylotarg received approval by the FDA in September 2017 for adults with newly diagnosed CD33-positive acute myeloid leukemia, and adults and children 2 years and older with relapsed or refractory CD33-positive AML.