FDA Approves Daunorubicin-Cytarabine Combination for AML Subtypes
Approval was based on data from a randomized phase 3 trial in which researchers compared the efficacy of the daunorubicin-cytarabine combination with that of a standard regimen.
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.
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.
- 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.