WASHINGTON, May 18, 2026— The U.S. Food and Drug Administration (FDA) approved decitabine and cedazuridine tablets (Inqovi®) in combination with venetoclax for the treatment of adults with newly diagnosed acute myeloid leukemia (AML) who are 75 years or older, or whose health conditions make standard intensive chemotherapy unsafe or impractical.
“Older adults make up the majority of people diagnosed with AML, and unfortunately many are not eligible for or cannot tolerate intensive chemotherapy,” said Lore Gruenbaum, Ph.D., Chief Scientific Officer of Blood Cancer United. “This FDA approval provides the first all-oral treatment option for these patients.”
The fixed-dose combination of decitabine and cedazuridine was specifically designed for oral delivery of decitabine and was already approved in the U.S. to treat adults with myelodysplastic syndrome or chronic myelomonocytic leukemia. It is now available in combination with venetoclax for patients with AML as well.
The decision was based on results from the ASCERTAIN trial in which 41.6% of patients achieved complete remission, with a median time to remission of two months. The median duration of remission was not reached at the time the data were analyzed, but the range among treated patients was 0.5 to 16.3 months.
Blood Cancer United is focused on cures and better quality of life
Blood Cancer United has two main goals for the research the organization funds. The search for cures for every form of blood cancer continues. But with so many patients living years, decades, or even a lifetime with blood cancer, Blood Cancer United also wants treatment to meet patients where they want to be, improving their quality of life during and after treatment.
Most people with AML are older, and many have other serious health conditions. All-oral treatment options are especially important for these patients, reducing the need to make frequent trips to hospitals or chemotherapy infusion centers for treatment.
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