In response to the FDA approval of obecabtagene autoleucel for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia, the panel requested the addition of obecabtagene autoleucel for this indication.

In response to the FDA approval of revumenib 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, the panel requested the addition of revumenib for this indication.

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

·        ALL-9: Request the addition of revumenib as treatment in KMT2A-rearranged relapsed/refractory disease for Ph+ B-ALL, Ph- B-ALL, and T-ALL. Include footnote, “Revumenib may be used as continuation therapy post-remission, including post-HCT.” Include footnote, “Revumenib is FDA approved 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.”

·         ALL-D 1 of 28: Under “Mutation Profile Principles”, request the addition of revumenib as treatment in relapsed/refractory acute lymphoblastic leukemia with KMT2A translocations and add the corresponding reference.       

·        ALL-D 3 of 28, ALL-D 4 of 28, ALL-D 10 of 28, ALL-D 12 of 28, ALL-D 19 of 28, ALL-D 21 of 28: Request addition of revumenib as “Other Recommended Regimen, Low Intensity” for KMT2A-rearranged relapsed/refractory ALL and add the corresponding reference.

·         ALL-D 26 of 28, ALL-D 27 of 28, and ALL-D 28 or 28: Request addition of revumenib as “Preferred Regimen” for KMT2A-rearranged ALL to the tables for Regimens For Relapsed or 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.”