The European Commission (EC) has approved INAQOVI (oral decitabine and cedazuridine) as monotherapy for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (AML) who are ineligible for standard induction chemotherapy.
INAQOVI, developed by Otsuka Pharmaceutical and Astex Pharmaceuticals, is the first oral hypomethylating agent to be licensed in the EEA in this patient population.
The EC decision is based on the results from the Phase III ASCERTAIN clinical trial investigating the pharmacokinetic exposure equivalence of the novel oral fixed-dose combination versus intravenous (IV) decitabine in AML patients.
The current treatment options for adults with AML are hospital-administered IV chemotherapy infusions or regimens based on parenterally administered hypomethylating agents, with treatment cycles typically extending for five to seven days.
The decitabine and cedazuridine fixed-dose combination showed pharmacokinetic exposure equivalence to a standard five-day regimen of IV decitabine 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.
By inhibiting cytidine deaminase in the gut and liver, INAQOVI is designed to allow for oral daily administration of decitabine over five days in a given cycle to achieve comparable systemic exposure to IV decitabine administered with the same dosing regimen.