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FDA Approves Therapy to Decrease Infection Risk Following Stem Cell Transplant


Rye Brook, N.Y., April 25, 2023 – On Monday, April 17, the U.S. Food and Drug Administration (FDA) approved omidubicel-onlv (Omisirge®) to reduce the risk of infection for patients 12 and older who have a planned stem cell transplantation following radiation or chemotherapy.

Stem cell transplants are a common treatment for blood cancers. To prepare for transplant, patients may receive high-intensity chemotherapy with or without radiation to kill the remaining cancerous cells. However, this can lead to a decrease in a certain type of white blood cells known as neutrophils, leaving patients vulnerable to serious infections. Omidubicel speeds recovery of these infection-fighting immune cells.
“This approval marks an advance for cell-based therapies, which use modified cells from either the patient’s own body, or in this case a donor,” said LLS Chief Scientific Officer Lee Greenberger, Ph.D. “This new treatment is an important new option for patients because it can help with recovery of the body’s white blood cells quickly after transplant reducing the possibility of infection.” 

The FDA based its decision to approve omidubicel on data from a trial that included 125 patients between the ages of 12 and 65 years with confirmed diagnoses of blood cancer. 

Patients treated with omidubicel had neutrophil recovery within a median of 12 days following one-time omidubicel treatment. Whereas patients who received the standard treatment had neutrophil recovery within a median of 22 days. Within 100 days after the stem cell transplant, patients treated with omidubicel also had a significantly lower risk of developing a bacterial or fungal infection. 

Patients should be aware that the use of omidubicel could be associated with severe adverse reactions including graft versus host disease, which occurs when a donor’s cells (referred to as the graft) consider the patient’s healthy cells (or the host) as foreign and attacks them. 

“This new treatment is a big step forward that may help improve patient outcomes,” said Dr. Greenberger. “LLS was one of the earliest funders of cell-based therapies and this approval adds to the available data we have about the effectiveness of these treatments.” 

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