The FDA Approves An Expanded Chemotherapy Treatment For Acute Myeloid Leukemia to Include Children

 

Cancer Network recently reported that Jazz Pharmaceuticals’ Vyxeos was approved by the FDA to treat therapy-related pediatric patients one year or older who were newly diagnosed with acute myeloid leukemia (AML).

The same approval applies to AML with myelodysplasia-related changes for pediatric patients ages one or older.

Vyxeos (CPX-351) is an encapsulated combination of cytarabine (a chemotherapy agent) and daunorubicin which is an anthracycline antibiotic.

Cytarabine combined with an anthracycline is considered the standard of care for newly diagnosed AML patients or others with blood-related malignancies. But the primary focus is on patients who have relapsed or are refractory (do not respond to treatment).

The recommended ratio of cytarabine to daunorubicin is 5:1. The drugs maintain this ratio for twenty-four hours after infusion.

Researchers believe that compared to non-liposomal therapy, encapsulation may produce a greater therapeutic effect in patients with relapsed blood-related malignancies. The encapsulation may also provide improved tolerability.

The FDA’s approval was based on data from two trials (CPX-MA-1201 and AAML1421) as well as data from the CPX351-301 study. (Vyxeos’ list of adverse reactions is listed here).

The research team found no difference in toxicity from the drug combination with respect to age.

Although pediatric patients may account for a small number of AML patients, there is still an urgent need for more effective treatment for these children.

Rose Duesterwald

Rose Duesterwald

Rose became acquainted with Patient Worthy after her husband was diagnosed with Acute Myeloid Leukemia four years ago. He was treated with a methylating agent While he was being treated with a hypomethylating agent, Rose researched investigational drugs being developed to treat relapsed/refractory AML.

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