FDA approves CytoCell CDx for Revumenib-Revuforj treatment of KMT2A mutated acute leukemia

The U.S. Food and Drug Administration (FDA) recently approved the CytoCell KMT2A Cleavage FISH Probe Kit PDx as a companion diagnostic kit (CDx) with Revumenib (Revuforj). This decision marks an important development in the field of acute leukemia treatment. Revimenib is a new type of Menin inhibitor , specifically used to treat relapsed or refractory acute leukemia (including AML, ALL) with KMT2A translocation in adult and pediatric patients 1 year old and above. The approval of this companion diagnostic kit allows clinicians to use CytoCell PDx to detect KMT2A rearrangements in patients with acute leukemia, thereby quickly and effectively determining whether the patient is eligible for treatment with revemenib.

The development and subsequent marketing authorization of the CytoCell KMT2A Cleavage FISH Probe Kit PDx demonstrates the efforts and innovation of clinical scientists and regulatory experts in the field of acute leukemia, aiming to provide safer and more effective diagnostics for patients affected by this serious disease. The emergence of this companion diagnosis not only improves the accuracy of treatment, but also brings new possibilities for personalized medicine.

In terms of approved indications for revimenib,The FDA approved it in November 2024 for the treatment of relapsed or refractory KMT2A-rearranged acute leukemia. This approval is based on a comprehensive evaluation of data obtained from the AUGMENT-101 Phase 1/2 clinical trial (NCT04065399), as well as other relevant information. In this clinical trial, revimenib showed good efficacy. In patients with relapsed or refractory acute myeloid leukemia and acute lymphoblastic leukemia with KMT2A rearrangement, the incidence of complete remission (CR) reached 21.2% (95% CI, 13.8%-30.3%), successfully achieving the primary endpoint of the study. In addition, the incidence of CRh (partial hematological recovery) is also an important indicator to evaluate the effect of this treatment. The study results showed that the median duration of CRh was 6.4 months (95% CI, 2.7-unestimated), which provides patients with new treatment hope.

Not only that,In June 2025, the FDA granted priority review to the supplemental new drug application (sNDA) of Revimani for relapsed or refractory NPM1 mutant AML, further promoting the application of Revumeni in the treatment of leukemia. The positive key data presented in the AUGMENT-101 trial not only support this application, but also provide valuable reference for academia and clinical practice. The results of the NPM1 study cohort were presented at the European Hematology Association (EHA) Annual Meeting in June 2025. The data showed that the combined incidence of CR and CRh was 26% (n=20/77; 95% CI, 17%-37%), and the median duration of CR and CRh response was 4.7 months (95% CI, 2.1-8.2), the median time between first CR and CRh was 2.8 months (range, 0.9-8.8). Of the 20 patients who achieved CR or CRh, minimal residual disease (MRD) status was assessed in 19, with 63% (n=12) having a negative MRD result, demonstrating the potential of revimenib in controlling disease.

In general,The approval of CytoCell KMT2A Cleavage FISH Probe Kit PDx as CDx accompanying Revimainib is not only a positive response to research and medical work in the field of acute leukemia, but also brings new treatment options and hope to patients. The combination of drugs and companion diagnostics further promotes the development of precision medicine and reflects the continuous progress and innovation of modern medicine in personalized treatment.

Reference materials:https://www.drugs.com/monograph/revumenib.html