Expanding Cells, Expanding Access: Gamida Cell’s Omisirge Debuts New Donor Source For Stem Cell Transplant

Pink Sheet’s Drug Review Profile follows the FDA’s navigation of the first expanded umbilical cord blood graft with the first indication grounded in neutrophil recovery and infection incidence data.

Drug Review Profile: Omisirge
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Gamida Cell Ltd.’s Omisirge (omidubicel-onlv) will be the first substantially modified cord blood-based stem cell graft source for allogeneic hematopoietic progenitor cell transplantation following FDA approval, using the Israeli company’s stem cell expansion and enhancement technology to improve clinical outcomes with umbilical cord blood grafts – and in doing so, address a significant health inequity.

The FDA approved Omisirge on 17 April 2023 for adult and pediatric patients 12 years and older with blood cancers who are planned for umbilical cord blood transplantation following myeloablative conditioning

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