medwireNews: The US FDA has approved the use of gemtuzumab ozogamicin for several groups of patients with CD33-positive acute myeloid leukemia (AML).
The antibody–drug conjugate may now be given to newly diagnosed patients alongside daunorubicin and cytarabine chemotherapy, following results of the ALFA-0701 phase III trial of patients aged 50–70 years.
In addition, gemtuzumab ozogamicin monotherapy may also now be prescribed to patients with a new diagnosis of AML, as well as to adults and pediatric patients aged over 2 years with relapsed or refractory CD33-positive AML.
These recommendations follow data from the AML-19 trial of treatment-naïve patients aged over 75 years or aged 65–71 years who were unwilling or unable to undergo intensive chemotherapy, and from the MyloFrance-1 study of patients with their first relapse.
The FDA draws attention to the boxed warning for hepatotoxicity and the recommendation of a lower dose and different schedule for gemtuzumab ozogamicin than previously recommended.
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