The US Food and Drug Administration has granted approval to Gamida Cell for Omisirge (omidubicel-onlv), a substantially modified allogeneic (donor) cord blood-based cell therapy.

This therapy helps to pace up the recovery of neutrophils (a subset of white blood cells) in the body and lower risk infection.

Omisirge is intended for use in adults and pediatric patients aged 12 years and above with blood cancers planned for umbilical cord blood transplantation after a myeloablative conditioning regimen i.e. treatment such as radiation or chemotherapy).

US FDA’s Center for Biologics Evaluation and Research director Peter Marks said: “Today’s approval is an important advance in cell therapy treatment in patients with blood cancers.

“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.”

Blood cancers are a form of cancer caused by uncontrolled growth of cells in the blood, disrupting the ability of blood cells to perform their normal functions.

Omisirge is to be administered as a single intravenous dose.

It is made up of human allogeneic stem cells from umbilical cord blood that are processed and then cultured with nicotinamide, which is a kind of vitamin B3.

Every dose is patient-specific, featuring healthy stem cells from an allogeneic pre-screened donor, implying it comes from a different individual instead of the patient’s own cells.

Reference：

https://www.pharmaceutical-business-review.com/news/fda-approval-cell-therapy-omisirge-blood-cancer/