FDA Approves Omisirge to Reduce Infection Risk in Patients With Blood Cancer

The Food and Drug Administration (FDA) approved Omisirge (omidubicel-onlv) to reduce the risk of infection in children and adults aged 12 years and older with blood cancers who have a planned umbilical cord blood transplantation after a myeloablative conditioning regimen, such as radiation or chemotherapy, according to the agency.

Omisirge is a made with donor cord blood and works to quicken the recovery of neutrophils (a type of white blood cell), which can fight infections.

“Today’s approval is an important advance in cell therapy treatment in patients with blood cancers,” said Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, in a press release from the agency. “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.”

Before undergoing stem cell transplantation — which is a common treatment for patients with blood cancer — a patient will have their cells removed, sometimes via chemotherapy or radiotherapy, to make room for the new donor cells. This process can drastically weaken the immune system and make them more prone to infections, which could be deadly.

Omisirge is an intravenous therapy that, after administered once, can help recover a patient’s immune system. The therapy is made of umbilical cord blood that is processed with a form of vitamin B3 called nicotinamide that can help stimulate the production of neutrophils, according to the American Physiological Society.

This FDA approval was based on a multicenter trial that compared Omisirge to transplantation of umbilical cord blood in 125 patients with blood cancers who were between the ages of 12 and 65 years old.

Findings showed that 87% of patients who were given Omisirge achieved neutrophil recovery, with an average of 12 days after treatment, compared to 83% in the umbilical cord group. For the latter group, the average time to neutrophil recovery was 22 days.

Within 100 days after transplantation, 39% of patients in the Omisirge group experienced a bacterial or fungal infection compared to 60% of those in the umbilical cord group.

However, side effects were seen in patients treated Omisirge. Similar to umbilical cord products, Omisirge comes with a Boxed Warning label for infusion reactions, graft-versus-host disease (GVHD), engraftment syndrome and graft failure.

The most common side effects seen with the therapy were infections, GVHD and infusion reactions, highlighting the importance of patients and providers monitoring for these complications.

For more news on cancer updates, research and education, don’t forget to subscribe to CURE®’s newsletters here.