Oral chemo option to be considered for AML in Europe
The European medicines regulator has started reviewing a submission from Japanese drugmaker Otsuka Pharmaceutical (TYO: 4578) for its acute myeloid leukemia (AML) therapy ASTX727.
Developed by its subsidiary Astex Pharmaceuticals, Otsuka is seeking approval to market the oral fixed-dose combination of decitabine and cedazuridine as an option for AML in the first-line setting.
The current standard of care for AML is hospital-administered intravenous chemotherapy infusions, or for those who are not eligible, parenterally administered hypomethylating agents.
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