Summaries of Must-Read Clinical Literature, Guidelines, and FDA Actions
FDA Approves Vyxeos for 2 Types of AML
FDA news release; 2017 Aug 3
The FDA has approved Vyxeos (daunorubicin and cytarabine) for the treatment of adults with 2 types of acute myeloid leukemia (AML).
Indications: Vyxeos is a liposomal combination of daunorubicin and cytarabine that is indicated for the treatment of adults with newly-diagnosed therapy-related AML or AML with myelodysplasia-related changes.
Dosage and administration:
- Induction: daunorubicin 44 mg/m2 and cytarabine 100 mg/m2 via IV infusion over 90 minutes on days 1, 3, and 5 and on days 1 and 3 for subsequent cycles, if needed.
- Consolidation: daunorubicin 29 mg/m2 and cytarabine 65 mg/m2 via IV infusion over 90 minutes on days 1 and 3.
Efficacy and safety: Approval is based on a randomized trial in which patients who received Vyxeos lived longer than those who received separate treatments of daunorubicin and cytarabine.
Side effects/risks: The most common adverse reactions are hemorrhagic 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.
FDA approves first treatment for certain types of poor-prognosis acute myeloid leukemia. [news release]. Silver Spring, MD: FDA. August 3, 2017. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm569883.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery. Accessed August 7, 2017.
Vyxeos [package insert]. Palo Alto, CA: Jazz Pharmaceuticals, Inc. 2017. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209401s000lbl.pdf. Accessed August 7, 2017.