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On November 27, 2023, the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation to mocravimod (also known as KRP203), a novel synthetic sphingosine-1-phosphate receptor modulator, to improve outcome after allogeneic hematopoietic stem cell transplantation (allo-HSCT) in patients with hematologic malignancies.1
Mocravimod was previously granted Orphan Drug Designation by the U.S. FDA and the European Medicines Agency (EMA) for the treatment of patients with acute myeloid leukemia undergoing allo-HSCT.2 The safety and efficacy of mocravimod, both as an adjunctive and maintenance therapy, for patients with acute myeloid leukemia receiving allo-HSCT is currently being investigated in the phase III MO-TRANS trial (NCT05429632), which will enroll around 250 adult patients.1
Which patients should be considered for allo-HSCT?
During the AML Hub Steering Committee meeting, held in November 2023, key opinion leaders met to discuss which patients should be considered for allo-HSCT.
Post-remission therapy for patients not proceeding to HSCT
During the AML Hub Steering Committee meeting in November 2023, key opinion leaders met to discuss postremission therapy for patients not proceeding to HSCT.
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