of each 28-day cycle until disease progression or unacceptable toxicity. Both trials provided comparison of exposure and safety in the first two cycles between oral decitabine combined with cedazuridine and intravenous decitabine and description of disease response with decitabine combined with cedazuridine. Comparison of disease response between the decitabine combined with cedazuridine and intravenous decitabine was not possible because all participants received decitabine combined with cedazuridine starting from Cycle 3. The FDA approval of decitabine combined with cedazuridine was based on clinical trial results which showed similar drug concentrations between intravenous decitabine and decitabine combined with cedazuridine. Additionally, about half of the participants who were formerly dependent on transfusions were able to no longer require transfusions during an 8-week period. The safety profile of decitabine combined with cedazuridine was also similar to intravenous decitabine. The FDA granted the approval of Inqovi to Astex Pharmaceuticals, Inc., a subsidiary of Otsuka Pharmaceutical Co. Ltd. References External links Combination drugs Orphan drugs Otsuka Pharmaceutical