FDA Approves Liposome-Encapsulated Combination of Daunorubicin-Cytarabine for Some Types of Poor-Prognosis AML

On August 3, 2017, the U.S. Food and Drug Administration (FDA) granted regular approval to a liposome-encapsulated combination of daunorubicin and cytarabine (Vyxeos) for the treatment of adults with newly diagnosed therapy-related acute myeloid leukemia (AML) or AML with myelodysplasia-related changes (AML-MRC), two types of AML having a poor prognosis. This is the first FDA-approved treatment specifically for patients with therapy-related AML or AML-MRC.

Approval was based on data from Study CLTR0310-301, a randomized (1:1), multicenter, open-label, active-controlled trial comparing the liposome-encapsulated daunorubicin-cytarabine to a standard combination of daunorubicin and cytarabine (7+3) in 309 patients 60–75 years of age with newly diagnosed therapy-related AML or AML-MRC. The liposome-encapsulated daunorubicin-cytarabine demonstrated an estimated median overall survival of 9.6 months compared with 5.9 months for the 7+3 control (hazard ratio = 0.69; 95% confidence interval [CI] = 0.52–0.90; P = .005).

The most common adverse reactions occurring in greater than 25% of patients treated with the liposome-encapsulated daunorubicin-cytarabine were hemorrhage events, febrile neutropenia, rash, edema, nausea, mucositis, diarrhea, constipation, musculoskeletal pain, fatigue, abdominal pain, dyspnea, headache, cough, decreased appetite, arrhythmia, pneumonia, bacteremia, chills, sleep disorders, and vomiting.

Each combination vial contains 44 mg daunorubicin and 100 mg cytarabine encapsulated together in liposomes. The volume of reconstituted treatment required for each dose is calculated based on the daunorubicin dose (mg/m2) using body surface area. Since the liposome-encapsulated combination is fixed-dose, and dosing based on the daunorubicin component, the corresponding cytarabine dose is included and does not need to be calculated.

For the first induction cycle, the recommended dose is (daunorubicin 44 mg/m2 and cytarabine 100 mg/m2) liposome via intravenous infusion over 90 minutes on days 1, 3, and 5. If needed, the same dose is administered on days 1 and 3 of second induction. The recommended dose for each cycle of consolidation therapy is (daunorubicin 29 mg/m2 and cytarabine 65 mg/m2) liposome via intravenous infusion over 90 minutes on days 1 and 3.

The prescribing information includes a boxed warning not to substitute the liposome-encapsulated combination with other daunorubin- or cytarabine-containing products. Full prescribing information is available on accessfda.gov.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.


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