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.
Keep reading Endpoints with a free subscription
Unlock this story instantly and join 170,200+ biopharma pros reading Endpoints daily — and it's free.