On July 7, 2020, the Food and Drug Administration (FDA) approved a new drug application (NDA) for Inqovi (decitabine and cedazuridine; Astex Pharmaceuticals Inc.) for treatment of adult patients with myelodysplastic syndromes (MDS) and chronic myelomonocytic leukemia (CMML).
Inqovi is an oral combination of decitabine, a nucleoside metabolic inhibitor, and cedazuridine, a cytidine deaminase inhibitor. It is indicated for treatment of adult patients with MDS, including previously treated or untreated, de novo and secondary MDS with the following French-American-British subtypes:
refractory anemia with ringed sideroblasts
refractory anemia with excess blasts
Intermediate-1, intermediate-2, and high-risk International Prognostic Scoring System groups
This new combination is taken orally; the recommended dosage is 1 tablet by mouth once daily for 5 consecutive days of each 28-day cycle. Decitabine was previously available as an intravenous infusion. FDA approval of Inqovi was supported by clinical trial results which showed similar drug concentrations between intravenous decitabine and Inqovi. Additionally, about half of the patients who were formerly dependent on transfusions were able to no longer require transfusions during an 8-week period. The safety profile of Inqovi was also similar to intravenous decitabine.
Food and Drug Administration (FDA). FDA Approves New Therapy for Myelodysplastic Syndromes (MDS) That Can Be Taken at Home. July 7, 2020. Available at: click here. Accessed July 8, 2020.