The US FDA has approved Omisirge to reduce the risk of infection in children & adults aged ≥12yrs. with hematologic malignancies who have a planned umbilical cord blood transplantation after a myeloablative conditioning regimen
The approval was based on the P-III trial evaluating omidubicel vs transplantation of umbilical cord blood in 125 patients which showed that 87% of patients with Omisirge achieved neutrophil recovery with a median of 12 days vs 83% in the umbilical cord group with a median of 22 days
39% vs 60% experienced a bacterial or fungal inf. within 100 days after transplantation. The safety profile was consistent with the expected AEs of Allo-HSCT, following myeloablative conditioning & the full results are available in Blood
Ref: Businesswire | Image: Gamida Cell
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