Omidubicel: First Approval

Omidubicel (omidubicel-onlv; Omisirge®) is a nicotinamide-modified stem cell graft derived from cord blood that is being developed by Gamida Cell for the treatment of haematological malignancies and haemoglobinopathies. In April 2023, omidubicel received its first approval in the USA for use in adults and children aged ≥ 12 years with haematological malignancies who are planned for cord blood transplantation following myeloablative conditioning to reduce the incidence of infection and the time to neutrophil recovery. This article summarizes the milestones in the development of omidubicel leading to this first approval.