Summary

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• Inqovi (decitabine and cedazuridine) is indicated for the treatment of adult patients with myelodysplastic syndromes (MDS), including previously treated and untreated, de novo and secondary MDS, with the following French-American-British subtypes: refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, and chronic myelomonocytic leukemia (CMML), as well as intermediate-1, intermediate-2, and high-risk International Prognostic Scoring System groups.
• This summary is based on the review of one randomized controlled trial(s). ^[1]
• Oral decitabine-cedazuridine demonstrated pharmacokinetic equivalence to intravenous decitabine, with total exposure (AUC) reaching 98.93% (90% CI 92.66-105.60), indicating similar effectiveness between the two formulations.
• The study did not report any significant differences in effectiveness among different population types or subgroups. The effectiveness was measured uniformly across the population as pharmacokinetic exposure (AUC).
• Common adverse events (Grade 3 or worse) included thrombocytopenia (61%), neutropenia (57%), and anemia (50%) among 133 participants.
• The incidence of serious adverse events was 31% (40/130) with oral decitabine-cedazuridine and 18% (24/132) with intravenous decitabine. Treatment-related deaths occurred in 2 participants on oral therapy (sepsis, pneumonia) and 3 participants on intravenous therapy (septic shock [n=2], pneumonia).