Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that t(KMT2A;v) status confers therapeutic sensitivity to Revumenib in patients with Acute Leukemias of Ambiguous Lineage.
The U.S. Food and Drug Administration (FDA) granted approval to revumenib for the treatment of adult and pediatric patients 1 year and older with relapsed or refractory acute leukemia with a lysine methyltransferase 2A gene (KMT2A) translocation.
This statement is based on a regulatory approval from the Food and Drug Administration:
REVUFORJ is a menin inhibitor indicated for the treatment of relapsed or refractory acute leukemia with a lysine methyltransferase 2A gene (KMT2A) translocation in adult and pediatric patients 1 year and older.