Shots:
- The US FDA has approved label expansion of Revuforj to treat pts (≥1yrs.) with nucleophosmin 1 (NPM1)-mutated r/r acute myeloid leukemia (AML) who have no satisfactory alternative treatment options
- Approval was supported by P-II results from the P-I/II (AUGMENT-101) trial, which showed a 23% CR + CRh rate (15/65), median response time of 2.8mos., & median CR/CRh duration of 4.5mos., published in Blood and presented at EHA’25
- Safety review of Revuforj incl. 241 pts (207 adults, 34 pediatric) with r/r AML harboring NPM1 mutations or KMT2A translocations treated in clinical trials
Ref: Incyte | Image: Incyte | Press Release
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