The European Commission (EC) has approved Otsuka Pharmaceutical and Astex Pharmaceuticals’s Inaqovi (oral decitabine and cedazuridine) as a monotherapy in certain acute myeloid leukaemia (AML) patients.
The EC’s decision, which specifically applies to adults with newly diagnosed AML who are ineligible for standard induction chemotherapy, makes Inaqovi the first oral hypomethylating agent approved in the European Economic Area for this patient population.
AML is a rapidly progressing cancer of the blood and bone marrow and the most common form of acute leukaemia in adults. Within Europe, the incidence of AML is increasing, rising from 3.48 per 100,000 population in 1976 to 5.06 in 2013.
Current treatment options for adults with AML range from hospital-administered intravenous (IV) chemotherapy infusions or, for those who are unable to receive chemotherapy, regimens based on parenterally administered hypomethylating agents.
By inhibiting cytidine deaminase in the gut and liver, Otsuka and Astex’s decitabine and cedazuridine fixed-dose combination 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.
The EC’s approval is supported by results from the late-stage ASCERTAIN trial, in which the fixed-dose combination demonstrated pharmacokinetic exposure equivalence to a standard five-day regimen of IV decitabine.
In addition to the EC approval, the European Medicines Agency previously agreed to a paediatric investigation plan for the oral combination treatment, which the partners say represents “an important milestone for the prospect of furthering clinical studies in children with AML”.
A paediatric investigation plan is a development plan aimed at ensuring that the necessary data is obtained through studies of children to support the authorisation of a medicine for this demographic in Europe.
The EC approval comes just over a month after Astex and MSD – known as Merck & Co in the US and Canada – expanded their drug discovery collaboration with the goal of identifying small-molecule candidates with activity towards a tumour suppressor protein.