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Otsuka Pharmaceuticals incannounces the approval of Inqovi (decitabine/cedazuridine inhibitors/titabinin), for the treatment of myelogenmic abnormal syndrome (MDS) and chronic granulocytic mononucleic leukemia (CMML) adult patients with the U.SFood and DrugAdministration (
FDA)Photo Source:Inqovi as an oral low-methylated agent, taken once daily for five consecutive days, 28 days for a treatment cycleThis approval is an important step forward in the field of MDS treatment, where patients can not need to go to the hospital for intravenous treatment"At this critical time, we remain committed to providing new options for cancer patients," said Richard Pazdur, director of the Office of Oncology at the FDA's Center for Drug Evaluation and Research"
FDA approval is supported by Inqovi's Phase III ASCERTAIN study, which was previously evaluated in adult patients with medium-risk MDSthe results, presented at the American Society of Hematology (ASH) meeting last December, showed that five days of continuous oral indocland can reach similar drug concentrations with intravenous sitabins, reaching the primary end of the experimentAbout half of patients who relied on blood transfusions before needed them for eight weeksAt the same time, the safety results were consistent with intravenous injections and did not have clinically significant gastrointestinal toxicity
