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Innovative Cell Therapy, Omisirge, Receives FDA Approval to Reduce Infection Risk in Blood Cancer Treatments

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The FDA has approved Omisirge (omidubicel-onlv), a modified allogeneic cord blood-based cell therapy designed to speed up the recovery of neutrophils and reduce infection risk. Omisirge is intended for use in adults and pediatric patients aged 12 and older with blood cancers who are undergoing umbilical cord blood transplantation after a myeloablative conditioning regimen.

Blood cancers, which represent about 10% of all cancer cases in the U.S., disrupt the normal functions of blood cells. Stem cell transplantation is a common treatment, with umbilical cord blood being one source of healthy stem cells. However, treatments like radiation or chemotherapy can weaken patients’ immune systems, increasing the risk of severe infections.

Omisirge, administered as a single intravenous dose, consists of human allogeneic stem cells from umbilical cord blood processed and cultured with nicotinamide. The therapy’s safety and effectiveness were supported by a randomized study involving 125 subjects. Results showed that 87% of subjects receiving Omisirge achieved neutrophil recovery with a median of 12 days, compared to 83% in the control group with a median of 22 days. Additionally, fewer Omisirge recipients experienced bacterial or fungal infections.

Potential severe side effects include infusion reactions, graft versus host disease, engraftment syndrome, and graft failure. Common adverse reactions are infections, GvHD, and infusion reactions. The FDA granted regular approval of Omisirge to Gamida Cell Ltd., with the therapy receiving Priority Review, Breakthrough Therapy, and Orphan designations.

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