What's Happening?
The U.S. Food and Drug Administration (FDA) has granted De Novo Classification for the CytoCell KMT2A Breakapart FISH Probe Kit PDx, developed by OGT, a Sysmex Group company. This kit is now authorized as a companion diagnostic for Syndax's menin inhibitor, REVUFORJ, which is used in treating relapsed or refractory acute leukaemia with KMT2A gene translocation in patients aged one year and older. The kit detects KMT2A rearrangements, which are prevalent in acute leukaemia cases, providing a rapid and accessible test to identify patients eligible for REVUFORJ treatment. This development marks a significant advancement in precision oncology, offering new treatment avenues for patients with challenging leukaemia cases.
Why It's Important?
The FDA's authorization of the CytoCell KMT2A Breakapart FISH Probe Kit PDx is a critical step in advancing precision medicine for acute leukaemia. The ability to accurately identify patients with KMT2A rearrangements allows for targeted treatment with REVUFORJ, potentially improving outcomes for a patient group with historically poor prognoses. This development underscores the importance of precision diagnostics in oncology, enabling more personalized and effective treatment strategies. The approval also highlights the role of innovative diagnostic tools in enhancing clinical decision-making and patient care in the U.S. healthcare system.
