Abbey Jenkins, Gamida Cell CEO

Gami­da Cell wins FDA ap­proval for new cord blood-based ther­a­py for can­cer pa­tients

The FDA on Mon­day ap­proved Is­rael-based Gami­da Cell’s Omisirge (omidu­bi­cel-on­lv), an al­lo­gene­ic cord blood-based cell ther­a­py used to quick­en the re­cov­ery of white blood cells for can­cer pa­tients.

The ap­proval of the sin­gle in­tra­venous dose, com­posed of hu­man al­lo­gene­ic stem cells from a donor’s um­bil­i­cal cord blood that are processed and cul­tured with nicoti­namide (a form of vi­t­a­min B3), was based on a study of 125 sub­jects with blood can­cer. The study, ac­cord­ing to FDA, found that 87% ran­dom­ized to re­ceive Omisirge achieved neu­trophil re­cov­ery with a me­di­an of 12 days fol­low­ing treat­ment with the prod­uct. That com­pared to 83% of sub­jects who were ran­dom­ized to re­ceive um­bil­i­cal cord blood trans­plan­ta­tion and who achieved neu­trophil re­cov­ery with a me­di­an of 22 days.

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