Gemtuzumab Ozogamicin Approaches EU Approval for CD33+ AML

February 26, 2018 – The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended approval of gemtuzumab ozogamicin for use in combination with daunorubicin and cytarabine as a frontline treatment for patients aged 15 years and older with previously untreated, de novo CD33-positive acute myeloid leukemia (AML), except acute promyelocytic leukemia. The recommendation was based on the phase III ALFA-0701 … (leggi tutto)