Curis Gets FDA Orphan Drug Designation For CA-4948 For Treatment Of AML And MDS

Curis Inc. (CRIS) said Monday that it has received Orphan Drug designation from the U.S. Food and Drug Administration for CA-4948, a first-in-class, small molecule inhibitor of IRAK4 and Curis's most advanced therapeutic in clinical development.

CA-4948 targets IRAK4-L, the oncogenic isoform of IRAK4 preferentially expressed by the majority of patients with acute myeloid leukemia or AML and myelodysplastic syndromes (MDS) and has shown broad clinical activity in Phase 1 trials in patients with relapsed or refractory (R/R) AML/MDS.

Orphan Drug Designation is granted by the FDA to drugs intended to treat rare disorders that affect fewer than 200,000 people in the U.S.

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