3 August 2017 - The U.S. FDA today approved Vyxeos for the treatment of adults with two types of acute myeloid leukaemia: newly diagnosed therapy-related AML or AML with myelodysplasia-related changes. 

Vyxeos is a fixed-combination of chemotherapy drugs daunorubicin and cytarabine.

The safety and efficacy of Vyxeos were studied in 309 patients with newly diagnosed t-AML or AML-MRC who were randomised to receive Vyxeos or separately administered treatments of daunorubicin and cytarabine. The trial measured how long patients lived from the date they started the trial (overall survival). Patients who received Vyxeos lived longer than patients who received separate treatments of daunorubicin and cytarabine (median overall survival 9.56 months vs. 5.95 months).

The FDA granted this application priority review and breakthrough therapy designations. Vyxeos also received orphan drug designation, which provides incentives to assist and encourage the development of drugs for rare diseases.

Read FDA press release