OTSKF - Otsuka's oral drug combo for leukemia gets review in EU

• The European Medicines Agency (EMA) accepted Astex Pharmaceuticals' application seeking approval for the oral fixed-dose combination of decitabine and cedazuridine (ASTX727) as an initial treatment of adults with acute myeloid leukemia (AML) who are not eligible for standard induction chemotherapy.
• Astex, a unit of Otsuka ( OTCPK:OTSKF ) ( OTCPK:OTSKY ) said the marketing authorization application (MAA), was backed by data from a phase 3 trial, dubbed ASCERTAIN, which showed the equivalence of the novel oral fixed-dose combination of decitabine/cedazuridine (sold as Inqovi by Taiho Oncology) versus IV decitabine.
• The company added that the current standard of care for AML is hospital-administered intravenous (IV) chemotherapy infusions or parenterally administered hypomethylating agents for those patients not eligible for chemotherapy.

For further details see: