European Commission approves Mylotarg to treat acute myeloid leukemia- Pfizer.

Pfizer Inc. announced that the European Commission has approved Mylotarg (gemtuzumab ozogamicin) 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 (AML), except acute promyelocytic leukemia (APL). 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.

AML is a rapidly progressing, life-threatening blood and bone marrow cancer. If left untreated, patients with AML will die within months, if not weeks, of their disease. AML is the most common type of acute leukemia in adults and accounts for approximately 80% of all cases of acute leukemia. About 16,800 people are expected to be newly diagnosed with AML in Europe annually. 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 III randomized, open-label study (ALFA-0701) 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 (AML), and adults and children 2 years and older with relapsed or refractory CD33-positive AML.