OGT announced that the U.S. Food and Drug Administration (FDA) has granted their De Novo Classification Request for the CytoCell KMT2A Breakapart FISH Probe Kit PDx as a companion diagnostic (CDx) for Syndax’s first-in-class menin inhibitor, REVUFORJ (revumenib).
Revuforj is FDA approved for the treatment of relapsed or refractory (R/R) acute leukemia with a lysine methyltransferase 2A gene (KMT2A) translocation in adult and pediatric patients one year and older.
OGT’s CytoCell KMT2A Breakapart FISH Probe Kit PDx detects clinically relevant rearrangements that occur in patients with acute leukemia, providing a robust, accessible, rapid turnaround test for KMT2Ar detection that will maximize the ability for clinicians to quickly identify patients who may be eligible for treatment with Revuforj. It is estimated that more than 95% of patients with KMT2Ar acute leukemia have a KMT2A translocation, a type of rearrangement that occurs when part of one chromosome breaks and fuses to a different chromosome.
The emergence of precision therapies, such as the menin inhibitor Revuforj (an oral inhibitor of the menin–KMT2A interaction), offers new avenues for potentially improving outcomes for patients with these challenging acute leukemia cases.
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