FDA Approves Omisirge for Patients with Blood Cancers to Quicken the Recovery of Neutrophils Following Stem Cell Transplantation

April 28, 2023

On April 17, 2023, the U.S. Food and Drug Administration approves Omisirge (omidubicel-onlv), a novel cell therapy used in adults and pediatric patients (older than 12 years) to fasten the recovery of neutrophils after receiving stem cell transplantation as treatment for different blood cancers. The drug, delivered as a single intravenous dose, contains nicotinamide-processed human allogeneic stem cells from umbilical cord blood of pre-screened donors.

“Today’s approval is an important advance in cell therapy treatment in patients with blood cancers,” mentioned Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “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.”

SOURCE: https://www.fda.gov/news-events/press-announcements/fda-approves-cell-therapy-patients-blood-cancers-reduce-risk-infection-following-stem-cell