FDA Approves Cell Therapy for Patients with Blood Cancers to Reduce Risk of Infection Following Stem Cell Transplantation
FDA has approved Omisirge
The U.S. Food and Drug Administration (FDA) has approved Omisirge, a modified allogeneic cord blood-based cell therapy for the treatment of blood cancers. The product is intended for use in adults and children aged 12 years and older who are planned for umbilical cord blood transplantation following myeloablative conditioning (radiation or chemotherapy). Omisirge quickens the recovery of neutrophils, a subset of white blood cells, and reduces the risk of infections associated with stem cell transplantation.
Blood cancers are a type of cancer caused by uncontrolled growth of cells in the blood, which disrupts the normal functions of blood cells. Stem cell transplantation is a common treatment for blood cancers, but it can weaken an individual's immune system, leading to severe and sometimes deadly infections.
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Omisirge is administered as a single intravenous dose, containing healthy stem cells from a pre-screened allogeneic donor that are processed and cultured with nicotinamide (a form of vitamin B3). The safety and effectiveness of Omisirge was supported by a randomized, multicenter study comparing transplantation of Omisirge to transplantation of umbilical cord blood, which enrolled a total of 125 subjects with confirmed blood cancers.
The study found that 87% of subjects who received Omisirge achieved neutrophil recovery with a median of 12 days following treatment, compared to 83% of subjects who received umbilical cord blood transplantation and achieved neutrophil recovery with a median of 22 days. Bacterial or fungal infections by 100 days following transplantation were seen in 39% of subjects receiving Omisirge versus 60% of subjects in the control group who received umbilical cord blood.
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Omisirge has the potential to cause severe side effects, including infusion reactions, graft versus host disease, engraftment syndrome, and graft failure. The most common adverse reactions associated with Omisirge included infections, graft versus host disease, and infusion reactions. Patients who receive Omisirge should be monitored for signs and symptoms of these side effects, as well as for transmission of serious infections or rare genetic diseases from the donor cells, and the risk of secondary malignancies.
This application received Priority Review, Breakthrough Therapy and Orphan designations. The FDA granted regular approval of Omisirge to Gamida Cell Ltd. The approval of Omisirge reflects the FDA's continued commitment to supporting the development of innovative therapies for life-threatening cancers.