The application is supported by positive results from the phase 3 ASCERTAIN clinical trial which demonstrated an exposure equivalence of an oral fixed-dose of decitabine and cedazuridine to a standard 5-day regimen of intravenous (IV) decitabine – the current standard of care for AML – using a two-cycle cross-over study design.
Safety findings for the fixed-dose combination of decitabine and cedazuridine were ‘generally consistent’ with those anticipated for IV decitabine, Otsuka reported…
