The US FDA has approved omidubicel-onlv, a hematopoietic stem cell transplant (HSCT) therapy, for the treatment of patients with severe aplastic anemia (SAA). Previously, omidubicel was indicated for adults and pediatric patients aged 12 years and older with hematologic malignancies. The new approval expands its use to adult and pediatric patients aged six years and older with SAA following reduced-intensity conditioning and without an available compatible donor.
Clinical evidence In an ongoing single-arm clinical trial of 17 patients, 86% of those treated with omidubicel achieved early and sustained neutrophil recovery at 100 days. The median time to neutrophil recovery was 11 days (range: 7 to 20 days). Dosage and administration Supplied as a suspension for intravenous use Recommended dose: One-time infusion administered in two separate bags The cultured fraction should be infused…
