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Gemtuzumab Ozogamicin Approaches EU Approval for CD33+ AML

Jason M. Broderick @jasoncology
Published: Monday, Feb 26, 2018

mcl
The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended approval of gemtuzumab ozogamicin (Mylotarg) 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.

 of gemtuzumab administered 14 days apart—could be combined safely with daunorubicin and cytarabine.
Prescribing information for Mylotarg (gemtuzumab ozogamicin) for injection, for intravenous use. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761060lbl.pdf. Accessed February 26, 2018.

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