Astex Pharmaceuticals Inc, a subsidiary of Otsuka Pharmaceutical Co Ltd, has received approval from the United States Food and Drug Administration (FDA) for its Inqovi (decitabine and cedazuridine) tablets intended for the treatment of adult patients with myelodysplastic syndromes (MDS) and chronic myelomonocytic leukaemia, it was reported on Tuesday.
The medicine is taken at home as one tablet orally once daily for five consecutive days of each 28-day cycle. This represents an important advance in treatment options for patients with MDS, a type of blood cancer, who previously needed to visit a health care facility to receive intravenous therapy.
The product received approval based on clinical trial results that indicated similar drug concentrations between intravenous decitabine and Inqovi. The US FDA has granted this application priority review status.
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