The FDA has approved CytoCell CDx, a diagnostic test developed by Ventana Medical Systems, inc., to identify patients with KMT2A-mutated acute myeloid leukemia (AML) eligible for treatment with revumenib. This approval marks a meaningful advancement in precision oncology, enabling clinicians to select patients most likely to benefit from the targeted therapy.
The diagnostic testS approval accompanies the anticipated FDA decision regarding Syndax Pharmaceuticals’ supplemental New drug Request (sNDA) for revumenib in relapsed or refractory KMT2A-mutant AML. KMT2A mutations occur in approximately 6-10% of AML cases and are associated with aggressive disease and poor outcomes. Identifying these patients is crucial, as revumenib has demonstrated promising clinical activity specifically in this subset. The cytocell CDx assay uses immunohistochemistry (IHC) to detect the KMT2A protein,providing a standardized and readily available method for identifying eligible patients.
Syndax announced on June 24, 2025, that the FDA granted priority review to the sNDA for revumenib. The approval of cytocell CDx is expected to facilitate broader access to revumenib for patients with this challenging leukemia subtype, pending a final decision on the sNDA. News regarding the diagnostic test was accessed September 22, 2025. Additional data on the sNDA can be found here: https://tinyurl.com/2p3yzrez. Further details on the CytoCell CDx assay are available here: https://tinyurl.com/nnfc84sh.
