7 July 2020 - Today, the Food and Drug Administration approved an oral combination of decitabine and cedazuridine (Inqovi, Astex Pharmaceuticals) for adult patients with myelodysplastic syndromes including the following:

• Previously treated and untreated, de novo and secondary myelodysplastic syndromes with the following French-American-British subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anaemia with excess blasts, and chronic myelomonocytic leukemia [CMML]) and
• Intermediate-1, intermediate-2, and high-risk International Prognostic Scoring System groups.

Inqovi was investigated in two open-label, randomised, crossover trials. Trial ASTX727-01-B included 80 adult patients with MDS (International Prognostic Scoring System [IPSS] Intermediate-1, Intermediate-2, or high-risk) or CMML and trial ASTX727-02 included 133 adult patients with myelodysplastic syndromes or CMML, including all French-American-British classification criteria and IPSS Intermediate-1, Intermediate-2, or high-risk prognostic scores.

Read FDA press release