FDA approves allogeneic cell therapy Omisirge for patients with blood cancers
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The FDA approved omidubicel-onlv, a donor cord blood-based cell therapy, to accelerate neutrophil recovery and reduce the risk for infection among patients with hematologic malignancies undergoing stem cell transplantation.
Omidubicel-onlv (Omisirge, Gamida Cell) is indicated for adults and children aged over 12 years with blood cancers planned for umbilical cord blood transplantation after a myeloablative conditioning regimen.
“Today’s approval is an important advance in cell therapy treatment in patients with blood cancers,” Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said in a press release. “Hastening the return of the body’s white blood cells can reduce the possibility of serious or overwhelming infection associated with stem cell transplantation. This approval reflects the FDA’s continued commitment to supporting development of innovative therapies for life-threatening cancers.”
The therapy uses Gamida Cell’s proprietary nicotinamide-based expansion technology that enables donor cells to grow while maintaining functionality. The final cryopreserved product — administered via IV — includes nicotinamide-expanded hematopoietic stem cells and differentiated immune cells, including T cells.
The FDA granted priority review to the agent last year based on results of a randomized phase 3 study that evaluated the efficacy and safety of omidubicel-onlv among 125 patients with leukemia, lymphoma or myelodysplastic syndrome undergoing hematopoietic stem cell transplantation.
In the study, 87% of patients who received omidubicel-onlv achieved neutrophil recovery a median 12 days after treatment, compared with 83% of patients assigned to umbilical cord blood transplantation who achieved neutrophil recovery in a median 22 days.
Researchers noted bacterial or fungal infections by day 100 following transplantation in 39% of patients who received omidubicel-onlv, compared with 60% of patients in the control group.
The most common adverse reactions associated with omidubicel-onlv included infections, graft-versus-host disease and infusion reactions.
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