预约演示
Gamida Cell receives FDA approval for blood cancer therapy
2023-04-18
临床结果临床3期细胞疗法上市批准突破性疗法
Omisirge is approved to treat haematologic malignancies in adult and paediatric patients aged 12 years and above. Credit: National Cancer Institute on Unsplash.
Omisirgebiotech company Gamidahaematologic malignanciesl from the US Food and Drug Administration (FDA) for Omisirge (omidNational Cancer InstituteCancern allogeneic cell therapy.
Omisirge has been approved to treat haematologic malignancies in adult and paediatric patients aged 12 years and above, who have planned to undergo umbilical cord blood transplantation after myeloablative conditioning for faster neutrophil recovery and reduced infection risk.
Gamida Cell CEO and presGamida Cell Jenkins stated: “FDA approval of Food and Drug Administration (FDA) the treatment omidubicel-onlvh haematologic malignancies that we believe may increase access to stem cell transplant and help improve patient outcomes.”
Omisirgelatory approval was based onhaematologic malignanciesdomised global Phase III clinical trial.infection
Gamida Cells treated with Omisirge took 12 days median time for neutrOmisirgecovery, compared to 22 days for standard cord blood.haematologic malignancies
In the trial, 39% of patients treated with Omisirge developed grade 2/3 bacterial or grade 3 fungal infections 100 days after transplantation, compared to 60% of patients in the standard cord blood group.
Omisirge’s safety profile Omisirged to be consistent with the expected adverse events of allogeneic haematopoietic stem cell transplantation after myeloablative conditioning.
The FDA previously granted priority review,Omisirgerough therapy designation and orphan drug designation to the therapy.
The therapy is a nicotinamide-modified allogeneic hematopoietic progenitor cell therapy manufactured at Gamida Cell’s good manufacturing practice-compliant manufacturing facility in Kiryat Gat, Israel.
CellFDAGene Therapy coverage on Pharmaceutical Technology is supported by Cytiva.
Editorial content is independently produced and follows the highest standards of journalistic integrity.Gamida Cellsors are not involved in the creation of editorial content.
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