Otsuka files for EMA authorization of Inaqovi

The European subsidiary of Japan’s Otsuka (TYO: 4578) announced the submission of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for the combination therapy of Inaqovi (oral decitabine and cedazuridine) with venetoclax for the treatment of patients with newly diagnosed acute myeloid leukemia (AML) who are not eligible for standard induction chemotherapy.

AML is a type of cancer that affects the bone marrow and the blood, which typically occurs when certain genes or chromosomes mutate.1 It is the most common form of acute  leukemia and is predominately diagnosed in adults over 60 years of age. Within Europe, the incidence of AML has increased, with a 17% five-year survival rate for adults.

Otsuka noted that the application is supported by data from the Phase I/II ASCERTAIN-V clinical trial investigating the safety and efficacy of the all-oral decitabine-cedazuridine and venetoclax regimen in of patients with newly diagnosed AML who are not eligible for standard induction chemotherapy. The study met its primary endpoint, with complete remission (CR) achieved in 46.5% of participants at a median of 2.4 months. Furthermore, among participants who achieved CR, 80% maintained remission at 6 months and 75.3% at 12 months.