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08-08-2017 | FDA | News


Liposomal daunorubicin–cytarabine formulation available for high-risk secondary AML

medwireNews: The FDA has given regular approval for a liposome-encapsulated combination of daunorubicin and cytarabine for patients with two types of acute myeloid leukemia (AML) associated with a poor prognosis.

The agent may be used in patients with a new diagnosis of AML associated with receipt of chemotherapy or radiotherapy, and in those with AML showing myelodysplasia-related changes.

The approval is based on findings from the CLTR0310-301phase III trial showing that the liposomal formulation offered significantly better overall survival than standard cytarabine and daunorubicin in patients aged 60–75 years with high-risk secondary AML.

Each vial of the liposomal agent contains daunorubicin 44 mg and cytarabine 100 mg, and dosing should be calculated on the basis of the daunorubicin component, with a recommended dose of 44 mg/m2 over a 90-minute infusion on days 1, 3, and 5 of the induction cycle. Consolidation therapy should be given at a dose of 29 mg/m2 for daunorubicin (65 mg/m2 for cytarabine) over 90 minutes on days 1 and 3.

The agent is to be marketed with a boxed warning that it should not be substituted with other formulations containing daunorubicin or cytarabine.

By Lynda Williams

medwireNews is an independent medical news service provided by Springer Healthcare. © 2017 Springer Healthcare part of the Springer Nature group

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