Allogeneic cell therapy approval to pave the way for future therapies in this class

The FDA has approved Gamida Cell’s stem cell transplant (SCT) therapy Omisirge (omidubicel) for the treatment of blood cancer patients undergoing SCT. The pivotal Phase III trial found Omisirge to be superior to standard cord blood in terms of median time to neutrophil engraftment (12 days versus 22 days), the incidence of Grade 2/3 bacterial or Grade 3 fungal infections (39% versus 60%), platelet recovery (55% versus 35% recovery by 42 days), and time spent out of hospital during the first 100 days (median, 61 versus 48). This therapy represents the first allogeneic cell therapy product indicated for SCT approved by the FDA and is set to address a real unmet need for patients unable to find a matched donor.