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FDA Approves Omisirge, a Cell Therapy for Blood Cancer Patients Undergoing Stem Cell Transplantation
Last Updated on April 17, 2023 by Daily News Staff
The FDA has recently approved a cell therapy called Omisirge (omidubicel-onlv) for patients with blood cancers who are undergoing stem cell transplantation. This allogeneic cord blood-based cell therapy can help speed up the recovery of neutrophils in the body, a type of white blood cell, and reduce the risk of infection. Omisirge is intended for use in adults and pediatric patients 12 years and older with blood cancers who are scheduled for umbilical cord blood transplantation following a myeloablative conditioning regimen.
Blood cancers can be fatal, and a stem cell transplant is a common treatment option. The process involves placing healthy stem cells into the body to help restore the normal production and function of blood cells. One source of healthy stem cells is umbilical cord blood. Before receiving this transplant, the patient will undergo a course of treatments to remove their own stem cells and prepare the body for the new stem cells. However, this process can weaken the patient’s immune system, making them vulnerable to infections.
Omisirge is composed of human allogeneic stem cells from umbilical cord blood that are processed and cultured with nicotinamide. It comes from a different individual rather than using the patient’s own cells. A randomized, multicenter study compared transplantation of Omisirge to transplantation of umbilical cord blood in subjects between the ages of 12 and 65 years. All subjects in the study had confirmed blood cancers. The efficacy of Omisirge was based on the amount of time needed for recovery of the subject’s neutrophils and the incidence of infections following transplantation.
The study showed that 87% of subjects who received Omisirge achieved neutrophil recovery with a median of 12 days following treatment with the product, compared to 83% of subjects who received umbilical cord blood transplantation and who 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.
However, treatment with Omisirge has the potential to cause severe side effects, which must be considered in assessing the risks and benefits of using this product. Patients who receive Omisirge should be monitored for signs and symptoms of infusion reactions, graft versus host disease, engraftment syndrome, graft failure, transmission of serious infections or rare genetic diseases from the donor cells, as well as lifelong for secondary malignancies.
Omisirge is a breakthrough therapy in cell therapy treatment for patients with blood cancers, and its approval reflects the FDA’s commitment to supporting the development of innovative therapies for life-threatening cancers. Although it carries some risks, Omisirge is expected to help many patients with blood cancers who are undergoing stem cell transplantation.
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