American Association for Cancer Research
Browse
ccr-21-4498_supplementary_figure_s3_suppfs3.pdf (228.86 kB)

Supplementary Figure from FDA Approval Summary: Decitabine and Cedazuridine Tablets for Myelodysplastic Syndromes

Download (228.86 kB)
journal contribution
posted on 2023-03-31, 23:44 authored by Nina Kim, Kelly J. Norsworthy, Sriram Subramaniam, Haiyan Chen, Michael L. Manning, Eliford Kitabi, Justin Earp, Lori A. Ehrlich, Olanrewaju O. Okusanya, Jonathon Vallejo, Brenda J. Gehrke, R. Angelo de Claro, Richard Pazdur
Supplementary Figure from FDA Approval Summary: Decitabine and Cedazuridine Tablets for Myelodysplastic Syndromes

History

ARTICLE ABSTRACT

On July 7, 2020, the Food and Drug Administration approved Inqovi (Otsuka Pharmaceutical Co.), an oral fixed-dose combination tablet comprising 35 mg decitabine, a hypomethylating agent, and 100 mg cedazuridine, a cytidine deaminase inhibitor (abbreviated DEC-C) for treatment of adult patients with myelodysplastic syndromes (MDS). Evidence of effectiveness of DEC-C was established in phase III ASTX727-02 (N = 133) in adults with MDS. The study involved a two-sequence crossover comparing DEC-C and intravenous (IV) decitabine 20 mg/m2 once daily for the first 5 days of each 28-day cycle in the first 2 cycles. From cycle 3 onward, patients received DEC-C. Five-day cumulative area under the curve (5-d AUC) of decitabine for DEC-C was similar to that of IV decitabine, with geometric mean ratio 0.99 (90% confidence interval: 0.93–1.06). Clinical benefit was supported by study ASTX727-02 and the similarly designed phase II study ASTX727-01-B (n = 80), with complete remission (CR) of 21% and 18% and median duration of CR 7.5 and 8.7 months, respectively. Adverse reactions were consistent with IV decitabine. Postmarketing assessments were issued to address the effect of cedazuridine on QT prolongation, food effect, moderate and severe hepatic impairment, and severe renal impairment on the pharmacokinetics and safety of DEC-C.

Usage metrics

    Clinical Cancer Research

    Categories

    Keywords

    Licence

    Exports

    RefWorks
    BibTeX
    Ref. manager
    Endnote
    DataCite
    NLM
    DC