FDA Approves Cell Therapy for Patients with Blood Cancers to Reduce Risk of Infection Following Stem Cell Transplantation (Catapult’s regulatory round-up – April)
The FDA has approved Omisirge (omidubicel-onlv) from Gamida Cell Ltd. Omisirge is a substantially modified allogeneic cord blood-based stem cell therapy, administered as a single intravenous dose and indicated for the treatment of hematological malignancies. It is intended for use in adults and pediatric patients over 12 years old who require stem cell transplant to treat their cancers and has shown accelerated neutrophil recovery and improved infection outcomes following the standard myeloablative conditioning regimen priot stem cell transplant. The application received Priority Review, Breakthrough Therapy and Orphan designations, reflecting the umet need for additional donor sources for stem cell transplant.
Published on the 2nd of May 2023 in Catapult’s April regulatory round-up.
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adelage (19 février 2024). FDA Approves Cell Therapy for Patients with Blood Cancers to Reduce Risk of Infection Following Stem Cell Transplantation (Catapult’s regulatory round-up – April). ELSIBI. Consulté le 13 janvier 2026 à l’adresse https://doi.org/10.58079/vv52





