DEC-C Plus Venetoclax May Quickly Replace IV HMA Regimens in AML

Following the May 2026 FDA approval of oral decitabine/cedazuridine (DEC-C; Inqovi) plus venetoclax (Venclexta) for newly diagnosed acute myeloid leukemia (AML) based on data from the phase 1/2 ASCERTAIN-V trial (NCT04657081), CancerNetwork® spoke with Courtney D. DiNardo, MD, MSCE, professor in the Department of Leukemia and the Division of Cancer Medicine at The University of Texas MD Anderson Cancer Center; and Michael R. Savona, MD, professor of internal medicine and cancer biology and director of the Hematologic Malignancies Research and Early Therapy Program at Vanderbilt University Medical Center. The pair discussed how quickly this all-oral regimen may replace traditional intravenous (IV) and subcutaneous hypomethylating agent (HMA) combinations in clinical practice. A regimen like DEC-C, DiNardo said, represents an “easy concept to pivot to” that may help improve quality of life among patients.

Transcript:

CancerNetwork: Given the May 2026 FDA approval of oral decitabine/cedazuridine DEC-C plus venetoclax based on the ASCERTAIN-V trial data, how quickly do you see this all-oral regimen replacing traditional IV/subcutaneous HMA combinations?

DiNardo: I think it will take over fairly quickly. I have already heard of different academic centers and community centers that have started doing this. It is not so much a new treatment program; we have all been very used to either azacitidine [Vidaza] or decitabine [Dacogen] in an IV or subcutaneous form, and now we have a pill version of decitabine. It is a pretty easy concept to pivot to, and certainly one that helps with quality of life for our patients [because] they are not spending as much time in the hospital setting.

Savona: We are familiar with [venetoclax], parenteral azacitidine, and decitabine, but we are also familiar with DEC-C, which has been around for a few years. There has already been significant uptake in the community. There are a lot of benefits to oral treatment, so it will be adopted rather quickly.

Reference

FDA approves oral combination of decitabine and cedazuridine tablets with venetoclax for newly diagnosed acute myeloid leukemia. News release. FDA. May 13, 2026. Accessed July 13, 2026. https://tinyurl.com/mv77f4fk