The US Food and Drug Administration (FDA) approved a daunorubicin and cytarabine combination for patients with therapy-related acute myeloid leukemia (t-AML) and AML with myelodysplasia-related changes (AML-MRC).1
The daunorubicin-cytarabine combination is administered from vials containing liposome-encapsulated 44 mg daunorubicin and 100 mg cytarabine. The combination is the first approval for these AML types, both of which carry a poor prognosis.
FDA approval was based on data from a randomized phase 3 trial (ClinicalTrials.gov Identifier: NCT01696084), in which researchers compared the efficacy of the daunorubicin-cytarabine combination with that of a standard regimen of 7-day cytarabine infusion plus daunorubicin on days 1, 2, and 3.
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Among 309 patients aged 60 to 75 years, median overall survival was 9.6 months with the experimental combination vs 5.9 months with the control (P = .005).
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Frequently observed adverse events included hemorrhage, febrile neutropenia, rash, edema, nausea, mucositis, and diarrhea.
Full prescribing information can be found here.
Reference
- FDA approves liposome-encapsulated combination of daunorubicin-cytarabine for adults with some types of poor prognosis AML [news release]. Silver Spring, MD: US Food and Drug Administration; August 3, 2017. https://www.fda.gov/Drugs/InformationOnDrugs/ ApprovedDrugs/ucm569950.htm. Accessed August 3, 2017.
