European Medicines Agency has granted Orphan Drug designation to ICT01, a humanized anti-butyrophilin 3A monoclonal antibody designed to selectively activate γ9δ2 T cells, for the treatment of acute myeloid leukemia. AML has high unmet medical need and limited treatment options for older or unfit patients who are not eligible for intensive chemotherapy.
With the recent FDA approval of daratumumab for high-risk smoldering multiple myeloma, the moment is ripe to revisit the evolution of our understanding of smoldering multiple myeloma. This development not only underscores the growing recognition of early intervention but also invites a broader reflection on the biological insights and therapeutic strategies that have shaped—and continue to shape—this transitional disease state.
