FDA grants priority review to omidubicel for stem cell transplant to treat blood cancers
Click Here to Manage Email Alerts
The FDA granted priority review to omidubicel, an investigational donor-based stem cell therapy for patients with hematologic malignancies undergoing allogeneic hematopoietic stem cell transplantation.
Omidubicel (Gamida Cell) is an ex vivo-expanded, cryopreserved graft derived from an entire cord blood unit.
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 is expected to make a decision on approval by Jan. 30, 2023.
The regulatory agency indicated it does not plan to conduct an advisory committee meeting as part of the biologics license application review, according to a Gamida Cell-issued press release.
The FDA based the priority review designation on results of a randomized phase 3 study that evaluated the efficacy and safety of omidubicel among patients with leukemia, lymphoma or myelodysplastic syndrome who were undergoing HSCT.
Investigators compared outcomes among omidubicel-treated patients with those of patients who underwent standard umbilical cord blood transplant.
As Healio previously reported, the trial achieved its primary endpoint by showing omidubicel produced a statistically significant reduction in time-to-neutrophil engraftment.
Omidubicel also conferred statistically significant improvement in all three secondary endpoints compared with standard umbilical cord blood transplant.
“If approved, omidubicel could become a treatment of choice for patients in need of an allo-HSCT transplant,” Julian Adams, PhD, CEO of Gamida Cell, said in the release. “We look forward to working with the FDA throughout the review process to bring omidubicel to patients as quickly as possible.”
Click Here to Manage Email Alerts