The FDA has approved Inqovi — a fixed-dose oral combination of decitabine and cedazuridine — for adult patients newly diagnosed with acute myeloid leukemia (AML) who are 75 years or older, or who have comorbidities that make standard intensive induction chemotherapy too risky. This marks a meaningful advance for a population that has historically had few safe treatment options. Decitabine is a hypomethylating agent that helps reactivate silenced tumor-suppressor genes, while cedazuridine inhibits the enzyme that normally breaks down oral decitabine, making effective blood levels achievable without IV administration. The oral formulation reduces hospital burden and improves convenience for frail or elderly patients. This approval expands the already approved use of Inqovi in myelodysplastic syndromes and adds a critical option in AML for those who cannot tolerate aggressive therapy.
