On July 7, 2020, the Food and Drug Administration authorized Inqovi (Otsuka Pharmaceutical Co.), an oral fixed-dose combination tablet containing 100 mg of cedazuridine and 35 mg of decitabine, a cytidine deaminase inhibitor, for the treatment of adult patients with myelodysplastic syndromes (MDS). MDS patients in ASTX727-Phase 02’s III (N=133) showed DEC-efficacy. A 2-sequence crossover was employed to compare DEC-C with intravenous (IV) decitabine 20 mg/m2 once daily over the first 5 days of each 28-day cycle in the experiment’s first 2 cycles. After cycle 3, patients started receiving DEC-C. Similar to the geometric mean ratio of decitabine for IV, the geometric mean ratio of decitabine for DEC-C was 0.99 (90% CI: 0.93-1.06). Similar phase II studies, ASTX727-01-B (n=80) and ASTX727-02, have CR rates of 21% and 18% and median CR durations of 7.5 and 8.7 months, respectively, respectively, both demonstrated therapeutic efficacy. Effects of decitabine IV were anticipated. Postmarketing reviews additionally looked into the effects of cedazuridine on QT prolongation, the lunch effect, moderate and severe hepatic impairment, and severe renal impairment on the pharmacokinetics and safety of DEC-C.

Source: aacrjournals.org/clincancerres/article-abstract/28/16/3411/707392/FDA-Approval-Summary-Decitabine-and-Cedazuridine?redirectedFrom=fulltext