FDA Approves Omisirge to Reduce Infection Risk in Blood Cancer Patients Undergoing Stem Cell Transplant

Omisirge is a single-dose, intravenous treatment made up of human allogeneic (donor) stem cells from umbilical cord blood. Each treatment is specifically manufactured for each patient.

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The FDA has approved a new cell therapy called omidubicel-onlv (Omisirge; Gamida Cell) to accelerate the recovery of neutrophils (a type of white blood cell that helps protect the body from infections) in patients 12 and older with blood cancers planning to undergo cord blood transplantation following treatment with a myeloablative conditioning regimen, such as chemotherapy or radiation.

In other words, Omisirge is a stem cell therapy that helps the body recover more quickly from cancer treatments that kill normal blood cells along with blood cancer cells, thus lowering the risk of infection.

“Today’s approval is an important advance in cell therapy treatment in patients with blood cancers,” Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research, said yesterday in a statement. “Hastening the return of the body’s white blood cells can reduce the possibility of serious or overwhelming infection associated with stem cell transplantation.”

Blood cancers account for about 10% of all U.S. cancer cases each year. Stem cell transplantation is a widely used treatment for blood cancers in which healthy stem cells are introduced into the body to restore normal blood cell production and function.

Omisirge is a single-dose, intravenous treatment made up of human allogeneic (donor) stem cells from umbilical cord blood. Each treatment is specifically manufactured for each patient.

“We have been successfully producing Omisirge for clinical studies and are now ready for full commercial production,” Michele Korfin, R.Ph., Chief Operating and Chief Commercial Officer at Gamida Cell, said on a conference call on April 18th. She continued “Omisirge is expected to be delivered to transplant centers within 30 days after the start of manufacturing.”

“The price for Omisirge is $338,000,” Korfin stated. “This price is based on extensive research and reflects the value proposition of Omisirge.”

On the conference call, Korfin explained that Gamida Cell’s health economic analyses have evaluated health care resource utilization of the product in studies. She said: “These data indicated a reduction in health care resource utilization for Omisirge-treated patients, including significantly shorter durations of hospitalization and significantly shorter intensive care unit time and less consultant visits, procedures, and transfusions than those in the control arm. This speaks to the value proposition of Omisirge to the healthcare system and a positive impact for patients. From the payer perspective, payers have been consistent in their feedback that for one-time therapies with curative intent, they will quickly support coverage and reimbursement.”

The safety and effectiveness of Omisirge were confirmed by a randomized, multicenter phase 3 clinical trial published in Blood. The study enrolled 125 patients aged of 12 to 65 with blood cancers. The efficacy of Omisirge was based on the recovery time of neutrophils and the incidence of infections following transplantation.

The study showed that 87% of patients randomized to receive Omisirge reached neutrophil recovery at a median of 12 days following treatment, versus 83% of patients who received standard umbilical cord blood grafts and achieved neutrophil recovery at a median of 22 days. The rate of infections 100 days following transplantation was lower in those receiving Omisirge.

Omisirge treatment also carries serious risks. The label carries boxed warnings for infusion reactions, graft-versus-host disease (GvHD), engraftment syndrome, and graft failure. Common adverse reactions of Omisirge in clinical trial participants included infections, GvHD, and infusion reactions.