FDA Approves New Drug for AML Subtype
The US Food and Drug Administration (FDA) has approved Mylotarg as a treatment for adults with CD33-positive acute myeloid leukemia (AML) and for patients aged 2 years or older with CD33-positive AML who have experienced a relapse or who were refractory to initial treatment.
FDA Approves New Treatment Option for Poor-Prognosis AML
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Mylotarg was originally approved in 2000 as a stand-alone therapy for older patients with CD33-positive AML who had experienced a relapse but was later taken off the markey due to suspect clinical benefit and safety concerns. The new approval includes a lower recommended dose, a different schedule in combination with chemotherapy or on its own, and a new patient population.
Serious adverse events associated with Mylotarg include low blood counts, infections, liver damage, hepatic veno-occlusive disease, infusion-related reactions, and hemorrhage.
Mylotarg comes with a boxed warning that severe or fatal liver damage—including veno-occlusive disease or sinusoidal obstruction syndrome—may occur.
FDA approves Mylotarg for treatment of acute myeloid leukemia [press release]. US Food and Drug Administration. September 1, 2017. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm574507.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery. Accessed September 1, 2017.