FDA Approves Cell Therapy for Blood Cancer Patients

Cell therapy has the potential to reduce the risk of infection after stem cell transplants.

The U.S. Food and Drug Administration (FDA) recently approved Omisirge (omidubicel-onlv), a donor-modified cord blood-based cell therapy to aid in a quicker recovery of neutrophils—a subset of white blood cells—in the body. This treatment is intended to help reduce the risk of further infection and is designed for those ages 12 and older experiencing blood cancers, already scheduled for planned cord blood transplants, along with the current use of chemotherapy and radiation. Stem cell transplants are common blood-cancer treatments, and Omisirge is a single intravenous dose that is patient-specific.

The FDA’s Center for Biologics Evaluation and Research director, Dr. Peter Marks, stated that the 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.”

As the Lord Leads, Pray with Us…

  • For Director Marks to seek God’s guidance as he heads biological research at the FDA.
  • For Commissioner Califf as he leads the Food and Drug Administration.
  • That the approved therapy would benefit and help heal those with blood cancer.

Sources: Food and Drug Administration


Back to top