Vyxeos Cancer Indication Expanded to Include Children

March 30, 2021 – The U.S. FDA has approved an expanded indication for Vyxeos® (daunorubicin/ cytarabine), manufactured by Jazz Pharmaceuticals. The drug is now indicated to treat newly diagnosed therapy-related acute myeloid leukemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC) in pediatric patients who are at least one year old. Previously, it was first FDA approved in 2017 for use in adults with the same diagnoses.

AML is a rare form of cancer in which the bone marrow produces abnormal white blood cells, red blood cells, or platelets. It typically occurs in older adults but can occur in children, and in all age groups is the deadliest form of leukemia. Both t-AML and AML-MRC are rare subtypes associated with an especially poor prognosis.

In clinical studies, Vyxeos demonstrated similar safety and pharmacokinetics (how a drug is processed in the body) in children as seen in adults. Recommended dosing is based on the patient’s body surface area, regardless of age. Vyxeos is administered two or three times per treatment cycle via 90-minute intravenous infusion, with a full course of treatment including up to four treatment cycles.

A black box warning cautions that Vyxeos is not interchangeable with other products containing its active pharmaceutical ingredients, daunorubicin and cytarabine. Healthcare providers should verify the drug name and dose prior to preparation and administration to avoid dosing errors.