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.
The FDA Oncologic Drugs Advisory Committee July 17 recommended against approval of a Blenrep-based regimen for the treatment of relapsed or refractory multiple myeloma, citing unacceptable rates of ocular toxicity and overall poor tolerability of the drug.
