Based on the FDA approval of revumenib for relapsed or refractory acute leukemia with a lysine methyltransferase 2A gene (KMT2A) translocation in adult and pediatric patients 1 year and older, add revumenib as a treatment option for KMT2A-rearranged, relapsed/refractory T-ALL based on data from the AUGMENT-101 trial.

We respectfully request the Panel’s consideration of the following additions to the pages noted below:

·         PEDALL-9: Request the addition of revumenib as a treatment in KMT2A-rearranged B-ALL relapsed disease for early or late first relapse and first relapse post-HCT. Include footnote, “Revumenib may be used as continuation therapy post-remission, including post-HCT.” Include footnote, “Revumenib is FDA approved for the treatment for the treatment of relapsed or refractory acute leukemia, including ALL, AML, and MPAL, with a lysine methyltransferase 2A gene (KMT2A) translocation in adult and pediatric patients 1 year and older.”  

·         PEDALL-10: Request the addition of revumenib as a treatment in KMT2A-rearranged relapsed/refractory T-ALL first relapse disease. Include footnote, “Revumenib may be used as continuation therapy post-remission, including post-HCT.” Include footnote, “Revumenib is FDA approved for the treatment for the treatment of relapsed or refractory acute leukemia, including ALL, AML, and MPAL, with a lysine methyltransferase 2A gene (KMT2A) translocation in adult and pediatric patients 1 year and older.”  

·         PEDALL-11: Request the addition of revumenib as a treatment in KMT2A-rearranged multiple relapsed/refractory disease. Include footnote, “Revumenib may be used as continuation therapy post-remission, including post-HCT.” Include footnote, “Revumenib is FDA approved for the treatment for the treatment of relapsed or refractory acute leukemia, including ALL, AML, and MPAL, with a lysine methyltransferase 2A gene (KMT2A) translocation in adult and pediatric patients 1 year and older.”  

·         PEDALL-G 7 of 13 and PEDALL-G 9 of 13: Request addition of revumenib for KMT2A-rearranged ALL to the tables for Regimens For Relapsed/Refractory ALL, and add the corresponding reference. Include footnote, “Revumenib can cause fatal or life-threatening differentiation syndrome. If differentiation syndrome is suspected, immediately initiate corticosteroid therapy and hemodynamic monitoring until symptom resolution.”