Posted by Michael Wonder on 23 Apr 2018
Mylotarg approved in the EU for the treatment of previously untreated, de novo, CD33-positive acute myeloid leukaemia in combination with chemotherapy
23 April 2018 - Pfizer today 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 leukaemia, except acute promyelocytic leukaemia.
Mylotarg is the first and only AML therapy approved in the European Union that targets CD33, an antigen expressed on AML cells in up to 90% of patients.
The European Commission’s approval of Mylotarg was based on data from an investigator-led, Phase 3 randomised, open-label study (ALFA-0701) in previously untreated, de novo patients. Mylotarg received approval by the U.S. FDA in September 2017 for adults with newly diagnosed CD33-positive acute myeloid leukaemia and adults and children 2 years and older with relapsed or refractory CD33-positive AML.
