19th Mar 2018 08:34
Vyxeos is a dual-drug liposomal encapsulation of daunorubicin and cytarabine combined in a 1:5 molar ratio, respectively. This managed access programme is for the treatment of adults aged 60 to 75 with newly-diagnosed, therapy-related, acute myeloid leukemia with myelodysplasia-related changes.
The first launches of the programme will be in the
Vyxeos received approvation from US Food & Drug Administration last August while it's not been approved for use outside
According to Clinigen, acute myeloid leukemia is a rapidly progressing and life-threatening blood cancer that starts from young white blood cells called granulocytes or monocytes which build up in the bone marrow - the soft inner part of the bones where new blood cells are made.
It is relatively rare with approximately 21,000 people in the US and 19,000 in the European Union diagnosed each year.
However, it is the most common type of acute aggressive leukemia in adults with variable treatment options and outcomes depending on the subtype of AML and the age of the patient.
"There is a huge unmet need for adults with AML where treatment options to date have been very few. Vyxeos provides the first FDA approved chemotherapy treatment for patients with certain types of high-risk AML in more than 40 years", said John Lagus, Clinigen's head of Managed Access.
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